FDA Orange Book · active-ingredient family
Cefotaxime sodium
Cefotaxime sodium: 3 brands, 14 generics; first approved Dec 29, 1983; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 14 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
14
Listed patents
0
Presentations
40
Brand (NDA) products
Originator applications
- CLAFORANRLDSTERIMAXNDA 050547—4 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 — EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued — - B BRAUNNDA 05079220042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2GM BASE INJECTABLE INJECTION Discontinued — EQ 1GM BASE INJECTABLE INJECTION Discontinued — - STERIMAXNDA 05059619854 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/ML INJECTABLE INJECTION Discontinued — EQ 20MG BASE/ML INJECTABLE INJECTION Discontinued — EQ 40MG BASE/ML INJECTABLE INJECTION Discontinued — EQ 40MG BASE/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (14)
Abbreviated applications
- CEFOTAXIME SODIUMHOSPIRAANDA 20313220162 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 — - CEFOTAXIME SODIUMCEPHAZONE PHARMAANDA 0653482010
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued — - CEFOTAXIME SODIUMAUROBINDO PHARMAANDA 06551720093 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 — - CEFOTAXIME SODIUMAUROBINDO PHARMA LTDANDA 0655162009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued — - WOCKHARDTANDA 06519720063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued — - CEFOTAXIME SODIUMHOSPIRA INCANDA 06529020063 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 — - CEFOTAXIME SODIUMHOSPIRA INCANDA 06529320062 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 — - CEFOTAXIME SODIUMHOSPIRA INCANDA 0652922006
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued — - CEFOTAXIME SODIUMLUPINANDA 06512420033 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 — - HIKMAANDA 06507220023 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 — - HIKMAANDA 0650712002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued — - FRESENIUS KABI USAANDA 06420020003 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 — - FRESENIUS KABI USAANDA 06420120002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 20GM BASE/VIAL INJECTABLE INJECTION Discontinued — - SANOFI AVENTIS USANDA 06265919872 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 —
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
43 yr 3 mo ago
Most recent approval
10 yr 8 mo ago
Approvals span 1983–2016 across 17 FDA applications.
Brand (NDA) 318%
Generic (ANDA) 1482%
Cefotaxime 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.
