Glimepiride
- Product NDC
- 82804-140
- 11-digit product format
- 828040140
- Labeler code
- 82804
- Product ID
- 82804-140_1f102e4c-1954-4f17-8c60-4dad79f25a25
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glimepiride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA077091
- Marketing category
- ANDA
- Marketing start
- 2005-10-06
- 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 table| Ingredient | Strength |
|---|
| GLIMEPIRIDE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6KY687524K |
| Rxcui | 199245 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82804-140-30 | Glimepiride | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 82804-140-90 | Glimepiride | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-140 | GLIMEPIRIDE TABLET [PROFICIENT RX LP] | 1 | Current NDC, 2 package rows | 20240927_1f102e4c-1954-4f17-8c60-4dad79f25a25.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-140-30 | 82804014030 | 30 TABLET in 1 BOTTLE (82804-140-30) | 30 tablet | 2024-09-11 | No | No | Current |
| 82804-140-90 | 82804014090 | 90 TABLET in 1 BOTTLE (82804-140-90) | 90 tablet | 2024-09-11 | No | No | Current |