Active ingredient
Repaglinide
20 finished FDA listings contain Repaglinide as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- REPAGLINIDE
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 7
- Strengths listed
- .5 mg/1 · 1 mg/1 · 2 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 73044
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 078555 | CHARTWELL RX | 2013-11-22 | 3 |
| ANDA 203820 | AUROBINDO PHARMA LTD | 2014-01-22 | 9 |
| ANDA 207209 | MACLEODS PHARMS | 2023-03-22 | 8 |
Official labeling on DailyMed
- REPAGLINIDE TABLET [BRYANT RANCH PREPACK] · version 100 · 2025-11-17
- REPAGLINIDE TABLET [NORTHSTAR RXLLC] · version 2 · 2025-09-17
- REPAGLINIDE TABLET [BRYANT RANCH PREPACK] · version 1 · 2025-06-09
- REPAGLINIDE TABLET [CHARTWELL RX, LLC] · version 1 · 2025-05-05
- REPAGLINIDE TABLET [BRYANT RANCH PREPACK] · version 1 · 2025-01-27
- REPAGLINIDE TABLET [BRYANT RANCH PREPACK] · version 1 · 2025-01-20
- REPAGLINIDE TABLET [AMERICAN HEALTH PACKAGING] · version 4 · 2024-10-24
- REPAGLINIDE TABLET [RISING PHARMA HOLDINGS, INC.] · version 7 · 2024-05-24
- REPAGLINIDE TABLET [AUROBINDO PHARMA LIMITED] · version 11 · 2024-05-16
- REPAGLINIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED] · version 1 · 2023-04-05
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.