FDA Orange Book · active-ingredient family
Ertapenem sodium
Ertapenem sodium: 1 brand, 6 generics; first approved Nov 21, 2001; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 6 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
6
Listed patents
0
Presentations
7
Brand (NDA) products
Originator applications
- MSD SUB MERCKNDA 0213372001
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AP
Generic (ANDA) products (6)
Abbreviated applications
- ERTAPENEM SODIUMQILU ANTIBIOTICSANDA 2180672024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AP - ERTAPENEM SODIUMSUN PHARMANDA 2091452023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Discontinued — - ERTAPENEM SODIUMGLANDANDA 2120402021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AP - ERTAPENEM SODIUMSAVIOR LIFETEC CORPANDA 2076472019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AP - ERTAPENEM SODIUMEUGIA PHARMAANDA 2091332018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AP - ERTAPENEM SODIUMACS DOBFAR SPAANDA 2087902018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INTRAMUSCULAR, INTRAVENOUS Rx AP
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
25 yr 1 mo ago
Most recent approval
1 yr 10 mo ago
Approvals span 2001–2024 across 7 FDA applications.
Brand (NDA) 114%
Generic (ANDA) 686%
Ertapenem 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.
