FDA Orange Book · active-ingredient family
Azithromycin
Azithromycin: 10 brands, 62 generics; first approved Nov 01, 1991; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 62 ANDA applications approved.
Brands (NDA)
10
Generics (ANDA)
62
Listed patents
0
Presentations
83
Brand (NDA) products
Originator applications
- THEA PHARMANDA 0508102007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SOLUTION/DROPS OPHTHALMIC Rx — - ZMAXRLDPF PRISM CVNDA 0507972005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2GM BASE/BOT FOR SUSPENSION, EXTENDED RELEASE ORAL Discontinued — - ZITHROMAXRLDPFIZERNDA 0507842002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET ORAL Rx AB - PFIZERNDA 0507331997
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - ZITHROMAXRLDPFIZERNDA 0507111996
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Rx AB - ZITHROMAXRLDPFIZERNDA 0507301996
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Discontinued — - ZITHROMAXRLDPFIZERNDA 05071019952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/5ML FOR SUSPENSION ORAL Rx AB EQ 200MG BASE/5ML FOR SUSPENSION ORAL Rx AB - ZITHROMAXRLDPFIZERNDA 0506931994
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/PACKET FOR SUSPENSION ORAL Discontinued — - ZITHROMAXRLDPFIZERNDA 0506701991
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE CAPSULE ORAL Discontinued — - AZITHROMYCINTEVA PARENTERALNDA 05080920062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 2.5GM BASE/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (62)
Abbreviated applications
- AZITHROMYCINZHEJIANG POLY PHARMANDA 21703620232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/5ML FOR SUSPENSION ORAL Rx AB EQ 200MG BASE/5ML FOR SUSPENSION ORAL Rx AB - AZITHROMYCINZYDUS PHARMSANDA 2132752023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — - AZITHROMYCINZYDUS PHARMSANDA 2130562023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET ORAL Discontinued — - AZITHROMYCINCARLSBADANDA 2113172022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — - AZITHROMYCINSTRIDES PHARMAANDA 2157722022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — - AZITHROMYCINSTRIDES PHARMAANDA 2157732022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET ORAL Discontinued — - AZITHROMYCINPHARMOBEDIENTANDA 2113182021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET ORAL Discontinued — - AZITHROMYCINCARLSBADANDA 2110682020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Rx AB - AZITHROMYCINALEMBICANDA 2117912020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Rx AB - AZITHROMYCINALEMBICANDA 2117922020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET ORAL Rx AB - AZITHROMYCINALEMBICANDA 2117932020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Rx AB - AZITHROMYCINTAROANDA 2115212019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/5ML FOR SUSPENSION ORAL Discontinued — - AZITHROMYCINCSPC OUYIANDA 2082502019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Rx AB - AZITHROMYCINBIONPHARMAANDA 2100002019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Rx AB - AZITHROMYCINBIONPHARMAANDA 2100012019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET ORAL Rx AB - AZITHROMYCINBIONPHARMAANDA 2099992018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Rx AB - AZITHROMYCINSUNSHINEANDA 2090452018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Rx AB - AZITHROMYCINSUNSHINEANDA 2090442018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET ORAL Rx AB - AZITHROMYCINSUNSHINEANDA 2090432018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Rx AB - AZITHROMYCINCSPC OUYIANDA 2082492018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET ORAL Rx AB - AZITHROMYCINAUROBINDO PHARMA LTDANDA 20920120182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/5ML FOR SUSPENSION ORAL Rx AB EQ 200MG BASE/5ML FOR SUSPENSION ORAL Rx AB - AZITHROMYCINSLATE RUN PHARMAANDA 2034122018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - AZITHROMYCINCSPC OUYIANDA 2075662018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Rx AB - AZITHROMYCINZYDUS LIFESCIENCESANDA 21114720182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/5ML FOR SUSPENSION ORAL Rx AB EQ 200MG BASE/5ML FOR SUSPENSION ORAL Rx AB - AZITHROMYCINAMNEALANDA 20566620182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/5ML FOR SUSPENSION ORAL Discontinued — EQ 200MG BASE/5ML FOR SUSPENSION ORAL Discontinued — - AZITHROMYCINAUROBINDO PHARMA LTDANDA 2073702018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Rx AB - AZITHROMYCINAUROBINDO PHARMA LTDANDA 2073982018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET ORAL Rx AB - AZITHROMYCINEPIC PHARMA LLCANDA 20753120182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/5ML FOR SUSPENSION ORAL Rx AB EQ 200MG BASE/5ML FOR SUSPENSION ORAL Rx AB - AZITHROMYCINRISINGANDA 2047322017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - AZITHROMYCINEUGIA PHARMAANDA 2032942015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - AZITHROMYCINCHARTWELL RXANDA 06548820152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/5ML FOR SUSPENSION ORAL Rx AB EQ 200MG BASE/5ML FOR SUSPENSION ORAL Rx AB - AZITHROMYCINLUPINANDA 0653982015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Rx AB - AZITHROMYCINLUPINANDA 0653992015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET ORAL Rx AB - AZITHROMYCINLUPINANDA 0654002015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Rx AB - AZITHROMYCINSUN PHARM INDS LTDANDA 0909232013
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - AZITHROMYCINAPOTEX CORPANDA 0655072011
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — - AZITHROMYCINAPOTEX CORPANDA 0655092011
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET ORAL Discontinued — - AZITHROMYCINAPOTEX CORPANDA 0655082011
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Discontinued — - AZITHROMYCINGLAND PHARMA LTDANDA 0655012009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - AZITHROMYCINHOSPIRAANDA 0655002009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - AZITHROMYCINHOSPIRAANDA 0655112009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - AZITHROMYCINPHARMOBEDIENTANDA 0655062009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - AZITHROMYCINTEVA PHARMSANDA 06541920082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/5ML FOR SUSPENSION ORAL Discontinued — EQ 200MG BASE/5ML FOR SUSPENSION ORAL Discontinued — - AZITHROMYCINCHARTWELL RXANDA 0654042008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Rx AB - AZITHROMYCINCHARTWELL RXANDA 0654052008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET ORAL Rx AB - AZITHROMYCINCHARTWELL RXANDA 0653022008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Rx AB - AZITHROMYCINEXTROVISANDA 0653662007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET ORAL Discontinued — - AZITHROMYCINPHARMOBEDIENTANDA 0653652007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — - AZITHROMYCINHIKMAANDA 0652652007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - AZITHROMYCINAUROBINDO PHARMA USAANDA 0653602007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Discontinued — - AZITHROMYCINSANDOZANDA 06529720062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/5ML FOR SUSPENSION ORAL Discontinued — EQ 200MG BASE/5ML FOR SUSPENSION ORAL Discontinued — - AZITHROMYCINPLIVAANDA 06524620062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/5ML FOR SUSPENSION ORAL Rx AB EQ 100MG BASE/5ML FOR SUSPENSION ORAL Rx AB - AZITHROMYCINFRESENIUS KABI USAANDA 0651792005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - AZITHROMYCINPLIVAANDA 0652252005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Rx AB - AZITHROMYCINPLIVAANDA 0652232005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET ORAL Rx AB - AZITHROMYCINRSPLIVAANDA 0652182005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Rx AB - AZITHROMYCINSANDOZANDA 0652112005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Rx AB - AZITHROMYCINSANDOZANDA 0652122005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET ORAL Rx AB - AZITHROMYCINSANDOZANDA 0652092005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Rx AB - AZITHROMYCINTEVAANDA 0651532005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — - AZITHROMYCINTEVAANDA 0651932005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET ORAL Rx AB - AZITHROMYCINTEVAANDA 0651502005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
35 yr 4 mo ago
Most recent approval
3 yr 1 mo ago
Approvals span 1991–2023 across 72 FDA applications.
Brand (NDA) 1014%
Generic (ANDA) 6286%
Azithromycin: 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.
