Glimepiride
- Product NDC
- 68071-2228
- 11-digit product format
- 680712228
- Labeler code
- 68071
- Product ID
- 68071-2228_1d7632a7-0f26-9e5d-e063-6294a90ad21f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glimepiride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA077091
- Marketing category
- ANDA
- Marketing start
- 2005-10-06
- Substance
- GLIMEPIRIDE
- Active strength
- 4 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 table| Ingredient | Strength |
|---|
| GLIMEPIRIDE | 4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6KY687524K |
| Rxcui | 199247 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-2228-6 | Glimepiride | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-2228 | GLIMEPIRIDE TABLET [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240719_abc187f1-8645-23e9-e053-2a95a90a64a7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-2228-6 | 68071222806 | 60 TABLET in 1 BOTTLE (68071-2228-6) | 60 tablet | 2020-07-31 | 0000-00-00 | No | No | Current |