FDA Orange Book · active-ingredient family
Cephapirin sodium
Cephapirin sodium: 1 brand, 5 generics; first approved Nov 17, 1986; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 5 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
5
Listed patents
0
Presentations
23
Brand (NDA) products
Originator applications
- APOTHECONNDA 050446—5 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 — EQ 4GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 20GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (5)
Abbreviated applications
- APOTHECONANDA 06296119884 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 4GM BASE/VIAL INJECTABLE INJECTION Discontinued — - CEPHAPIRIN SODIUMHIKMAANDA 06272019874 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 20GM BASE/VIAL INJECTABLE INJECTION Discontinued — - APOTHECONANDA 06272419862 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 — - CEPHAPIRIN SODIUMABRAXIS PHARMANDA 06272319865 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 4GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 20GM BASE/VIAL INJECTABLE INJECTION Discontinued — - APOTHECONANDA 061769—3 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 — EQ 4GM 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
40 yr 4 mo ago
Most recent approval
38 yr 6 mo ago
Approvals span 1986–1988 across 6 FDA applications.
Brand (NDA) 117%
Generic (ANDA) 583%
Cephapirin 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.
