FDA Orange Book · active-ingredient family
Ceftriaxone sodium
Ceftriaxone sodium: 3 brands, 39 generics; first approved Dec 21, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 39 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
39
Listed patents
0
Presentations
104
Brand (NDA) products
Originator applications
- B BRAUNNDA 05079620052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 2GM BASE/VIAL INJECTABLE INJECTION Rx AP - HOFFMANN LA ROCHENDA 05062419873 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/ML INJECTABLE INJECTION Discontinued — EQ 20MG BASE/ML INJECTABLE INJECTION Discontinued — EQ 40MG BASE/ML INJECTABLE INJECTION Discontinued — - ROCEPHINRLDHOFFMANN LA ROCHENDA 05058519845 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 500MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 1GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 2GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (39)
Abbreviated applications
- DEVA HOLDING ASANDA 21019720244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 500MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 1GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 2GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — - QILU ANTIBIOTICSANDA 2092182018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Rx AP - ASTRALANDA 09104920184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 500MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 1GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 2GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — - CEFTRIAXONE SODIUMHIKMAANDA 0907012017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Rx AP - CEFTRIAXONE SODIUMANDA REPOSITORYANDA 0911172017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Rx AP - QILU ANTIBIOTICSANDA 20370220164 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AP EQ 500MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AP EQ 1GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AP EQ 2GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AP - SAMSON MEDCLANDA 0900572014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100GM BASE/VIAL INJECTABLE INJECTION Rx — - AGILA SPECLTSANDA 0910682013
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued — - HOSPIRA INCANDA 20256320122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued — - BEDFORDANDA 0654752008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued — - BEDFORDANDA 06546520084 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 500MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 1GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 2GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — - AUROBINDO PHARMA LTDANDA 0655042008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued — - AUROBINDO PHARMA LTDANDA 06550520084 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 500MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 1GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 2GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — - ACS DOBFARANDA 06532920083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 2GM BASE/VIAL INJECTABLE INJECTION Rx AP - ACS DOBFARANDA 0653282008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Rx AP - EPIC PHARMA LLCANDA 06530520084 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AP EQ 500MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AP EQ 1GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AP EQ 2GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AP - HIKMA FARMACEUTICAANDA 06534220084 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AP EQ 500MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AP EQ 1GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AP EQ 2GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AP - WOCKHARDT BIO AGANDA 06539120073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AP EQ 500MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AP EQ 2GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AP - CEPHAZONE PHARMAANDA 06529420074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 500MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 1GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 2GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — - TEVA PHARMS USAANDA 06522720074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 500MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 1GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 2GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — - FACTA FARMAANDA 0652692007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued — - FACTA FARMAANDA 06526820072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 2GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — - LUPINANDA 0652632006
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued — - TEVAANDA 06526220062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 2GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — - APOTEXANDA 0651802006
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP - TEVAANDA 0652742006
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued — - FRESENIUS KABI USAANDA 0652522006
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued — - FRESENIUS KABI USAANDA 06524520064 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 500MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 1GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 2GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — - BAXTER HLTHCAREANDA 06522420052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/ML INJECTABLE INJECTION Rx — EQ 40MG BASE/ML INJECTABLE INJECTION Rx — - HOSPIRA INCANDA 06523120052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued — - HOSPIRA INCANDA 0652322005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued — - HOSPIRA INCANDA 06523020054 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 500MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 1GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 2GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — - SANDOZANDA 0651682005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Rx AP - SANDOZANDA 06516920054 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AP EQ 500MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AP EQ 1GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AP EQ 2GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AP - SANDOZ INCANDA 06520420052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued — - LUPINANDA 06512520034 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 500MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 1GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 2GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — - HOFFMANN LA ROCHEANDA 06323919933 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - HOFFMANN LA ROCHEANDA 06265419873 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued — - ROCHEANDA 06251019853 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION 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
42 yr 3 mo ago
Most recent approval
2 yr 8 mo ago
Approvals span 1984–2024 across 42 FDA applications.
Brand (NDA) 37%
Generic (ANDA) 3993%
Ceftriaxone 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.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
