Active ingredient
Acarbose
17 finished FDA listings contain Acarbose as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ACARBOSE
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 6
- Strengths listed
- 100 mg/1 · 25 mg/1 · 50 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 16681
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 078470 | HIKMA | 2008-05-07 | 6 |
| ANDA 090912 | STRIDES PHARMA | 2011-07-27 | 4 |
| ANDA 202271 | AVET LIFESCIENCES | 2012-02-07 | 7 |
Official labeling on DailyMed
- ACARBOSE TABLET [BRYANT RANCH PREPACK] · version 10 · 2026-08-12
- ACARBOSE TABLET [BRYANT RANCH PREPACK] · version 102 · 2026-07-20
- ACARBOSE TABLET [STRIDES PHARMA SCIENCE LIMITED] · version 10 · 2026-07-16
- ACARBOSE TABLET [PD-RX PHARMACEUTICALS, INC.] · version 29 · 2026-06-26
- ACARBOSE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] · version 24 · 2026-06-22
- ACARBOSE TABLET [CHARTWELL RX, LLC] · version 3 · 2025-12-10
- ACARBOSE TABLET [HIKMA PHARMACEUTICALS USA INC.] · version 11 · 2024-07-24
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.