Active ingredient
Eptifibatide
21 finished FDA listings contain Eptifibatide as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- EPTIFIBATIDE
- Dosage forms
- Injection, Injection, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 8
- Strengths listed
- .75 mg/ml · 2 mg/ml · 20 mg/10ml · 200 mg/100ml · 75 mg/100ml
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 75635
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 |
|---|---|---|---|
| ANDA 206127 | EUGIA PHARMA | 2015-12-08 | 3 |
| ANDA 204693 | SAGENT PHARMS INC | 2018-03-07 | 1 |
| ANDA 203258 | MYLAN LABS LTD | 2018-07-20 | 6 |
| ANDA 208554 | BAXTER HLTHCARE CORP | 2018-11-23 | 1 |
| ANDA 209864 | HAINAN POLY | 2019-01-25 | 4 |
| ANDA 213081 | QUAGEN | 2021-09-07 | 4 |
| ANDA 213599 | MEITHEAL | 2024-05-09 | 2 |
Official labeling on DailyMed
- EPTIFIBATIDE INJECTION, SOLUTION [AVENACY, LLC] · version 3 · 2026-07-29
- EPTIFIBATIDE INJECTION [BAXTER HEALTHCARE COMPANY] · version 13 · 2026-05-21
- EPTIFIBATIDE INJECTION [SLATE RUN PHARMACEUTICALS, LLC] · version 6 · 2026-02-10
- EPTIFIBATIDE INJECTION [SLATE RUN PHARMACEUTICALS, LLC] · version 6 · 2026-02-10
- EPTIFIBATIDE INJECTION, SOLUTION [HAINAN SHUANGCHENG PHARMACEUTICALS CO., LTD.] · version 9 · 2025-12-05
- EPTIFIBATIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] · version 6 · 2024-10-24
- EPTIFIBATIDE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] · version 8 · 2024-05-16
- EPTIFIBATIDE INJECTION [EUGIA US LLC] · version 7 · 2024-01-10
- EPTIFIBATIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] · version 3 · 2021-07-26
- EPTIFIBATIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] · version 5 · 2021-07-26
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.