Active ingredient
Ertapenem
20 finished FDA listings contain Ertapenem as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ERTAPENEM SODIUM
- Dosage forms
- Injection, Injection, Powder, Lyophilized, For Solution
- Routes
- Intramuscular, Intravenous
- Manufacturers / labelers
- 17
- Strengths listed
- 1 g/1 · 1 g/20ml
- Brand names in FDA listings
- Ertapenem, Ertapenem Sodium, Invanz
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 325642
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021337 | MSD SUB MERCK | 2001-11-21 | 3 |
| ANDA 208790 | ACS DOBFAR SPA | 2018-04-16 | 4 |
| ANDA 209133 | EUGIA PHARMA | 2018-06-25 | 2 |
| ANDA 207647 | SAVIOR LIFETEC CORP | 2019-03-19 | 3 |
| ANDA 212040 | GLAND | 2021-03-26 | 4 |
| ANDA 218067 | QILU ANTIBIOTICS | 2024-10-31 | 4 |
Official labeling on DailyMed
- INVANZ (ERTAPENEM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME LLC] · version 42 · 2026-04-09
- ERTAPENEM (ERTAPENEM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ENDO USA, INC.] · version 13 · 2026-04-09
- ERTAPENEM (ERTAPENEM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ENDO USA, INC.] · version 13 · 2026-04-09
- ERTAPENEM (ERTAPENEM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] · version 1 · 2026-01-19
- ERTAPENEM SODIUM (ERTAPENEM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NORTHSTAR RXLLC] · version 5 · 2025-12-25
- ERTAPENEM (ERTAPENEM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [QILU ANTIBIOTICS PHARMACEUTICAL CO., LTD.] · version 7 · 2025-09-05
- ERTAPENEM (ERTAPENEM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] · version 1 · 2025-08-22
- ERTAPENEM (ERTAPENEM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 2 · 2025-02-28
- ERTAPENEM SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA, INC.] · version 3 · 2024-11-08
- ERTAPENEM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] · version 3 · 2024-11-08
- ERTAPENEM INJECTION [EUGIA US LLC] · version 7 · 2024-07-10
- ERTAPENEM INJECTION [EUGIA US LLC] · version 10 · 2024-07-10
Showing the 12 most recent of 20 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.