Active ingredient
Miglitol
6 finished FDA listings contain Miglitol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- MIGLITOL
- Dosage forms
- Tablet, Coated
- Routes
- Oral
- Manufacturers / labelers
- 2
- Strengths listed
- 100 mg/1 · 25 mg/1 · 50 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 30009
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 203965 | ORIENT PHARMA | 2015-02-24 | 6 |
Official labeling on DailyMed
- MIGLITOL TABLET, COATED [PROFICIENT RX LP] · version 2 · 2022-04-26
- MIGLITOL TABLET, COATED [WESTMINSTER PHARMACEUTICALS, LLC] · version 2 · 2021-12-08
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.