FDA Orange Book · active-ingredient family
Cefepime hydrochloride
Cefepime hydrochloride: 3 brands, 9 generics; first approved Jan 18, 1996; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 9 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
9
Listed patents
0
Presentations
27
Brand (NDA) products
Originator applications
- B BRAUNNDA 05082120102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx — EQ 2GM BASE/VIAL INJECTABLE INJECTION Rx — - BAXTER HLTHCARENDA 05081720082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/50ML (EQ 20MG BASE/ML) INJECTABLE INJECTION Rx — EQ 2GM BASE/100ML (EQ 20MG BASE/ML) INJECTABLE INJECTION Rx — - MAXIPIMERLDHOSPIRA INCNDA 05067919963 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 —
Generic (ANDA) products (9)
Abbreviated applications
- CEFEPIME HYDROCHLORIDEHIKMAANDA 21440220242 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 - CEFEPIME HYDROCHLORIDEASTRALANDA 21272120202 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 — - SAMSON MEDCLANDA 2094082018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100GM BASE POWDER INTRAVENOUS Rx — - CEFEPIME HYDROCHLORIDESAGENT PHARMS INCANDA 09104820172 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 - CEFEPIME HYDROCHLORIDERSQILU ANTIBIOTICSANDA 20370420163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx — EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 2GM BASE/VIAL INJECTABLE INJECTION Rx AP - CEFEPIME HYDROCHLORIDEHOSPIRA INCANDA 20226820122 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 — - CEFEPIME HYDROCHLORIDECHARTWELL RXANDA 09029120103 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 — - CEFEPIME HYDROCHLORIDEACS DOBFARANDA 06544120082 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 - CEFEPIME HYDROCHLORIDEHOSPIRA INCANDA 06536920073 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 —
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
31 yr 2 mo ago
Most recent approval
2 yr 5 mo ago
Approvals span 1996–2024 across 12 FDA applications.
Brand (NDA) 325%
Generic (ANDA) 975%
Cefepime hydrochloride: 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.
