FDA Orange Book · active-ingredient family
Levothyroxine sodium
Levothyroxine sodium: 14 brands, 19 generics; first approved Aug 21, 2000; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 19 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
14
Generics (ANDA)
19
Listed patents
16
Next patent expiry
Aug 06, 2031
in 4 yr 11 mo
Brand (NDA) products
Originator applications
- ERMEZARLDMYLANNDA 2158092022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MCG/5ML SOLUTION ORAL Discontinued — - LEVOTHYROXINE SODIUMRLDRSHIKMANDA 2142532021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MCG/ML SOLUTION INTRAVENOUS Rx — - STEVENS JNDA 2140472020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MCG/5ML SOLUTION ORAL Rx — - LEVOTHYROXINE SODIUMRLDRSFRESENIUS KABI USANDA 21063220193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MCG/5ML (20MCG/ML) SOLUTION INTRAVENOUS Rx — 200MCG/5ML (40MCG/ML) SOLUTION INTRAVENOUS Rx — 500MCG/5ML (100MCG/ML) SOLUTION INTRAVENOUS Rx — - TIROSINT-SOLRLDIBSANDA 206977201615 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 13MCG/ML SOLUTION ORAL Rx — 25MCG/ML SOLUTION ORAL Rx — 50MCG/ML SOLUTION ORAL Rx — 75MCG/ML SOLUTION ORAL Rx — 88MCG/ML SOLUTION ORAL Rx — 100MCG/ML SOLUTION ORAL Rx — 112MCG/ML SOLUTION ORAL Rx — 125MCG/ML SOLUTION ORAL Rx — 137MCG/ML SOLUTION ORAL Rx — 150MCG/ML SOLUTION ORAL Rx — 175MCG/ML SOLUTION ORAL Rx — 200MCG/ML SOLUTION ORAL Rx — 37.5MCG/ML SOLUTION ORAL Rx — 44MCG/ML SOLUTION ORAL Rx — 62.5MCG/ML SOLUTION ORAL Rx — - LEVOTHYROXINE SODIUMRLDRSFRESENIUS KABI USANDA 20223120113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MCG/VIAL POWDER INTRAVENOUS Rx AP 200MCG/VIAL POWDER INTRAVENOUS Rx AP 500MCG/VIAL POWDER INTRAVENOUS Rx AP - TIROSINTRLDIBSANDA 021924200715 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025MG CAPSULE ORAL Rx — 0.05MG CAPSULE ORAL Rx — 0.075MG CAPSULE ORAL Rx — 0.1MG CAPSULE ORAL Rx — 0.125MG CAPSULE ORAL Rx — 0.15MG CAPSULE ORAL Rx — 0.112MG CAPSULE ORAL Rx — 0.137MG CAPSULE ORAL Rx — 0.088MG CAPSULE ORAL Rx — 0.175MG CAPSULE ORAL Rx — 0.2MG CAPSULE ORAL Rx — 0.013MG CAPSULE ORAL Rx — 0.0375MG CAPSULE ORAL Rx — 0.044MG CAPSULE ORAL Rx — 0.0625MG CAPSULE ORAL Rx — - THYRO-TABSRLDALVOGENNDA 021116200212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 - SYNTHROIDRLDABBVIENDA 021402200212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2 - LEVOXYLRLDKING PHARMSNDA 021301200112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB3 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB3 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB3 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB3 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB3 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB3 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB3 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB3 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB3 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB3 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB3 0.3MG TABLET ORAL Discontinued — - UNITHROIDRLDSTEVENS JNDA 021210200012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 - GENUS LIFESCIENCESNDA 021137200312 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 - EMD SERONO INCNDA 021292200212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025MG TABLET ORAL Discontinued — 0.05MG TABLET ORAL Discontinued — 0.075MG TABLET ORAL Discontinued — 0.088MG TABLET ORAL Discontinued — 0.1MG TABLET ORAL Discontinued — 0.112MG TABLET ORAL Discontinued — 0.125MG TABLET ORAL Discontinued — 0.137MG TABLET ORAL Discontinued — 0.15MG TABLET ORAL Discontinued — 0.175MG TABLET ORAL Discontinued — 0.2MG TABLET ORAL Discontinued — 0.3MG TABLET ORAL Discontinued — - CEDIPROF INCNDA 021342200212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3
Generic (ANDA) products (19)
Abbreviated applications
- LEVOTHYROXINE SODIUMALEMBICANDA 216370202612 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB2 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB2 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB2 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB2 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB2 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB2 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB2 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB2 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB2 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB2 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB2 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB2 - LEVOTHYROXINE SODIUMONESOURCE SPECIALTYANDA 21672920253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MCG/VIAL POWDER INTRAVENOUS Rx AP 200MCG/VIAL POWDER INTRAVENOUS Rx AP 500MCG/VIAL POWDER INTRAVENOUS Rx AP - LEVOTHYROXINE SODIUMXIROMEDANDA 2174952024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MCG/VIAL POWDER INTRAVENOUS Rx AP - LEVOTHYROXINE SODIUMAUROBINDO PHARMAANDA 21641420245 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.137MG TABLET ORAL Discontinued — 0.15MG TABLET ORAL Discontinued — 0.175MG TABLET ORAL Discontinued — 0.2MG TABLET ORAL Discontinued — 0.3MG TABLET ORAL Discontinued — - LEVOTHYROXINE SODIUMZYDUS PHARMSANDA 21706620233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MCG/VIAL POWDER INTRAVENOUS Rx AP 200MCG/VIAL POWDER INTRAVENOUS Rx AP 500MCG/VIAL POWDER INTRAVENOUS Rx AP - LEVOTHYROXINE SODIUMASCENT PHARMS INCANDA 215259202312 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB4 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB4 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB4 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB4 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB4 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB4 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB4 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB4 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB4 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB4 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB4 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB4 - LEVOTHYROXINE SODIUMMACLEODS PHARMSANDA 211417202212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 - LEVOTHYROXINE SODIUMWATSON LABS TEVAANDA 207588202212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 - LEVOTHYROXINE SODIUMANI PHARMSANDA 21325620213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.088MG CAPSULE ORAL Discontinued — 0.1MG CAPSULE ORAL Discontinued — 0.125MG CAPSULE ORAL Discontinued — - LEVOTHYROXINE SODIUMANI PHARMSANDA 21136920206 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.075MG CAPSULE ORAL Discontinued — 0.15MG CAPSULE ORAL Discontinued — 0.112MG CAPSULE ORAL Discontinued — 0.2MG CAPSULE ORAL Discontinued — 0.137MG CAPSULE ORAL Discontinued — 0.175MG CAPSULE ORAL Discontinued — - LEVOTHYROXINE SODIUMACCORD HLTHCAREANDA 212399202012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 - LEVOTHYROXINE SODIUMDR REDDYSANDA 2088372020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MCG/VIAL POWDER INTRAVENOUS Discontinued — - LEVOTHYROXINE SODIUMAMNEALANDA 210831201912 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025MG TABLET ORAL Discontinued — 0.05MG TABLET ORAL Discontinued — 0.075MG TABLET ORAL Discontinued — 0.088MG TABLET ORAL Discontinued — 0.1MG TABLET ORAL Discontinued — 0.112MG TABLET ORAL Discontinued — 0.125MG TABLET ORAL Discontinued — 0.137MG TABLET ORAL Discontinued — 0.15MG TABLET ORAL Discontinued — 0.175MG TABLET ORAL Discontinued — 0.2MG TABLET ORAL Discontinued — 0.3MG TABLET ORAL Discontinued — - LEVOTHYROXINE SODIUMLUPINANDA 209713201912 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3 - LEVOTHYROXINE SODIUMMAIA PHARMS INCANDA 20874920183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MCG/VIAL POWDER INTRAVENOUS Rx AP 200MCG/VIAL POWDER INTRAVENOUS Rx AP 500MCG/VIAL POWDER INTRAVENOUS Rx AP - LEVOTHYROXINE SODIUMPIRAMAL CRITICALANDA 20616320162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MCG/VIAL POWDER INTRAVENOUS Discontinued — 500MCG/VIAL POWDER INTRAVENOUS Discontinued — - LEVOTHYROXINE SODIUMPH HEALTHANDA 2053662015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MCG/VIAL POWDER INTRAVENOUS Discontinued — - LEVOTHYROXINE SODIUMMERCK KGAAANDA 076752200511 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025MG TABLET ORAL Discontinued — 0.05MG TABLET ORAL Discontinued — 0.075MG TABLET ORAL Discontinued — 0.088MG TABLET ORAL Discontinued — 0.1MG TABLET ORAL Discontinued — 0.112MG TABLET ORAL Discontinued — 0.125MG TABLET ORAL Discontinued — 0.15MG TABLET ORAL Discontinued — 0.175MG TABLET ORAL Discontinued — 0.2MG TABLET ORAL Discontinued — 0.3MG TABLET ORAL Discontinued — - LEVOTHYROXINE SODIUMMYLANANDA 076187200212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET ORAL Rx AB1,AB2,AB3,AB4
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9050307 | in 4 yr 11 mo | Product | |
| 9168239 | in 6 yr | Product | |
| 9168238 | in 6 yr | Product | |
| 9006289 | in 6 yr 1 mo | Product | |
| 9345772 | in 8 yr 6 mo | Product | |
| 11154498 | in 9 yr 11 mo | Product | |
| 9782376 | in 10 yr 4 mo | Product | |
| 11135190 | in 10 yr 4 mo | Product | |
| 12636270 | in 10 yr 4 mo | Product | |
| 10398669 | in 10 yr 4 mo | Product | |
| 11096913 | in 10 yr 7 mo | Product | |
| 10537538 | in 10 yr 7 mo | Product | |
| 10406108 | in 11 yr 7 mo | Product | |
| 10231931 | in 11 yr 7 mo | Product | |
| 11241382 | in 13 yr 2 mo | U-3757 | |
| 12564565 | in 18 yr 3 mo | Product |
Approval history
FDA approval span
First approval
26 yr 6 mo ago
Most recent approval
5 mo ago
Approvals span 2000–2026 across 33 FDA applications.
Brand (NDA) 1442%
Generic (ANDA) 1958%
Levothyroxine sodium: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
