Glimepiride
- Product NDC
- 71921-215
- 11-digit product format
- 719210215
- Labeler code
- 71921
- Product ID
- 71921-215_52fcdeaf-e64f-48bd-b90d-e7502b104ae1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glimepiride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Florida Pharmaceutical Products, LLC
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Glimepiride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLIMEPIRIDE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6KY687524K |
| Rxcui | 199245, 199246, 199247 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71921-215-01 | Glimepiride | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
| 71921-215-50 | Glimepiride | 500 in 1 BOTTLE | TABLET | 500 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71921-215 | GLIMEPIRIDE TABLET [FLORIDA PHARMACEUTICAL PRODUCTS, LLC] | 2 | Current NDC, 2 package rows | 20241022_8ff0de99-272e-4e68-9caf-69f3f146ac29.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 |
|---|
| 71921-215-01 | 71921021501 | 100 TABLET in 1 BOTTLE (71921-215-01) | 100 tablet | 2023-07-31 | No | No | Historical |
| 71921-215-50 | 71921021550 | 500 TABLET in 1 BOTTLE (71921-215-50) | 500 tablet | 2023-07-31 | No | No | Historical |