Glimepiride
- Product NDC
- 68071-3639
- 11-digit product format
- 680713639
- Labeler code
- 68071
- Product ID
- 68071-3639_1c336dcb-ba7c-a01b-e063-6294a90a4845
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glimepiride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA202112
- Marketing category
- ANDA
- Marketing start
- 2023-07-31
- Substance
- GLIMEPIRIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 |
|---|
| 68071-3639-8 | 68071363908 | 180 TABLET in 1 BOTTLE (68071-3639-8) | 180 tablet | 2024-07-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Glimepiride | NuCare Pharmaceuticals,Inc. | 2024-07-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |