Active ingredient
Glyburide
54 finished FDA listings contain Glyburide as their only active ingredient; 30 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- GLYBURIDE
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 17
- Strengths listed
- 1.25 mg/1 · 2.5 mg/1 · 3 mg/1 · 5 mg/1 · 6 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 4815
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 017532 | SANOFI AVENTIS US | 1984-05-01 | 3 |
| ANDA 074388 | TEVA | 1995-08-29 | 10 |
| ANDA 074686 | TEVA | 1999-04-20 | 2 |
| ANDA 090937 | HERITAGE | 2011-02-28 | 19 |
| ANDA 206749 | ZYDUS PHARMS | 2016-05-10 | 6 |
| ANDA 203379 | CADILA PHARMS LTD | 2019-01-04 | 14 |
Official labeling on DailyMed
- GLYBURIDE TABLET [REMEDYREPACK INC.] · version 4 · 2026-06-15
- GLYBURIDE TABLET [BRYANT RANCH PREPACK] · version 9 · 2026-05-20
- GLYBURIDE TABLET [REMEDYREPACK INC.] · version 8 · 2026-05-20
- GLYBURIDE TABLET [PREFERRED PHARMACEUTICALS INC.] · version 4 · 2026-05-11
- GLYBURIDE TABLET [NORTHWIND HEALTH COMPANY, LLC] · version 5 · 2026-02-26
- GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA, INC.] · version 17 · 2026-02-13
- GLYBURIDE TABLET [NORTHWIND HEALTH COMPANY, LLC] · version 4 · 2026-02-11
- GLYBURIDE TABLET [PREFERRED PHARMACEUTICALS INC.] · version 1 · 2026-01-29
- GLYBURIDE TABLET [A-S MEDICATION SOLUTIONS] · version 6 · 2026-01-21
- GLYBURIDE TABLET [NUCARE PHARMACEUTICALS,INC.] · version 2 · 2026-01-19
- GLYBURIDE TABLET [CHARTWELL RX, LLC] · version 3 · 2025-12-10
- GLYBURIDE TABLET [COUPLER LLC] · version 1 · 2025-12-09
Showing the 12 most recent of 37 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.