FDA Orange Book · active-ingredient family
Cefuroxime sodium
Cefuroxime sodium: 3 brands, 17 generics; first approved Oct 19, 1983; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 17 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
17
Listed patents
0
Presentations
35
Brand (NDA) products
Originator applications
- B BRAUNNDA 05078020012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 750MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1.5GM BASE/VIAL INJECTABLE INJECTION Discontinued — - PAI HOLDINGS PHARMNDA 05064319892 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 15MG BASE/ML INJECTABLE INJECTION Discontinued — EQ 30MG BASE/ML INJECTABLE INJECTION Discontinued — - ZINACEFRLDPAI HOLDINGS PHARMNDA 05055819833 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 750MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 1.5GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 7.5GM BASE/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (17)
Abbreviated applications
- SAMSON MEDCLANDA 06525120092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 225GM BASE/VIAL INJECTABLE INJECTION Discontinued — - CEFUROXIME SODIUMHOSPIRA INCANDA 06548320082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 750MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 1.5GM BASE/VIAL INJECTABLE INJECTION Discontinued — - CEFUROXIME SODIUMHOSPIRA INCANDA 0655032008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1.5GM BASE/VIAL INJECTABLE INJECTION Discontinued — - CEFUROXIME SODIUMHOSPIRA INCANDA 0654842008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 7.5GM BASE/VIAL INJECTABLE INJECTION Discontinued — - CEFUROXIME SODIUMRSHIKMAANDA 06504820042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 750MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AB EQ 1.5GM BASE/VIAL INJECTABLE INJECTION Rx AP - CEFUROXIME SODIUMHIKMAANDA 0650462004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 7.5GM BASE/VIAL INJECTABLE INJECTION Discontinued — - CEFUROXIME SODIUMFRESENIUS KABI USAANDA 06500120012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 750MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 1.5GM BASE/VIAL INJECTABLE INJECTION Discontinued — - CEFUROXIME SODIUMFRESENIUS KABI USAANDA 0650021998
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 7.5GM BASE/VIAL INJECTABLE INJECTION Discontinued — - CEFUROXIME SODIUMTEVA PHARMSANDA 0641911998
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 7.5GM BASE/VIAL INJECTABLE INJECTION Discontinued — - CEFUROXIME SODIUMTEVA PHARMSANDA 06419219982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1.5GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 750MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — - CEFUROXIME SODIUMACS DOBFAR SPAANDA 06412519972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 750MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AB EQ 1.5GM BASE/VIAL INJECTABLE INJECTION Rx AP - CEFUROXIME SODIUMACS DOBFAR SPAANDA 0641241997
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 7.5GM BASE/VIAL INJECTABLE INJECTION Discontinued — - CEFUROXIME SODIUMWATSON LABS INCANDA 06403519932 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 750MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 1.5GM BASE/VIAL INJECTABLE INJECTION Discontinued — - CEFUROXIME SODIUMWATSON LABS INCANDA 0640361993
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 7.5GM BASE/VIAL INJECTABLE INJECTION Discontinued — - ACS DOBFARANDA 06259119863 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 750MG BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 1.5GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 7.5GM BASE/VIAL INJECTABLE INJECTION Discontinued — - LILLYANDA 06259219862 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 750MG BASE/VIAL INJECTABLE INTRAVENOUS Discontinued — EQ 1.5GM BASE/VIAL INJECTABLE INJECTION Discontinued — - LILLYANDA 06259019862 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 750MG BASE/VIAL INJECTABLE INTRAVENOUS Discontinued — EQ 1.5GM 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 5 mo ago
Most recent approval
16 yr 10 mo ago
Approvals span 1983–2009 across 20 FDA applications.
Brand (NDA) 315%
Generic (ANDA) 1785%
Cefuroxime 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.
