Glimepiride
- Product NDC
- 72789-370
- 11-digit product format
- 727890370
- Labeler code
- 72789
- Product ID
- 72789-370_4bbf5d4c-4e06-6610-e063-6294a90a0041
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glimepiride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA202759
- Marketing category
- ANDA
- Marketing start
- 2012-06-29
- 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 |
|---|
| 72789-370-30 | Glimepiride | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-370 | GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.] | 4 | Current NDC, 1 package rows | 20240117_1450f455-a14a-4f9b-b3aa-dae49ea0c186.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 |
|---|
| 72789-370-30 | 72789037030 | 30 TABLET in 1 BOTTLE, PLASTIC (72789-370-30) | 30 tablet | 2024-01-16 | No | No | Current |