Glimepiride
- Product NDC
- 67046-1608
- 11-digit product format
- 670461608
- Labeler code
- 67046
- Product ID
- 67046-1608_48c0ccac-2fbc-0fe2-e063-6294a90a2a9c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glimepiride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA202112
- Marketing category
- ANDA
- Marketing start
- 2025-10-22
- Substance
- GLIMEPIRIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Glimepiride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLIMEPIRIDE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6KY687524K |
| Rxcui | 199246 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67046-1608-3 | Glimepiride | 30 in 1 BLISTER PACK | TABLET | 30 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-1608-3 | 67046160803 | 30 TABLET in 1 BLISTER PACK (67046-1608-3) | 30 tablet | 2025-10-22 | No | No | Historical |