Glimepiride
- Product NDC
- 71335-2561
- 11-digit product format
- 713352561
- Labeler code
- 71335
- Product ID
- 71335-2561_070cd0bc-0502-4130-b189-2305b26f4f91
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glimepiride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202112
- Marketing category
- ANDA
- Marketing start
- 2023-07-31
- Substance
- GLIMEPIRIDE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Glimepiride
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| GLIMEPIRIDE | 1 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 6KY687524K |
| Rxcui | 199245 |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 6KY687524K | GLIMEPIRIDE | 93479-97-1 | GLIMEPIRIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2561-1 | 71335256101 | 30 TABLET in 1 BOTTLE (71335-2561-1) | 30 tablet | 2025-01-28 | No | No | Historical |
| 71335-2561-2 | 71335256102 | 60 TABLET in 1 BOTTLE (71335-2561-2) | 60 tablet | 2025-01-28 | No | No | Historical |
| 71335-2561-3 | 71335256103 | 90 TABLET in 1 BOTTLE (71335-2561-3) | 90 tablet | 2025-01-28 | No | No | Historical |
| 71335-2561-4 | 71335256104 | 100 TABLET in 1 BOTTLE (71335-2561-4) | 100 tablet | 2025-01-28 | No | No | Historical |
| 71335-2561-5 | 71335256105 | 20 TABLET in 1 BOTTLE (71335-2561-5) | 20 tablet | 2025-01-28 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Glimepiride | Bryant Ranch Prepack | 2025-01-28 | HUMAN PRESCRIPTION DRUG LABEL | 1 |