Glimepiride
- Product NDC
- 68084-788
- 11-digit product format
- 680840788
- Labeler code
- 68084
- Product ID
- 68084-788_26cca05b-82f8-e191-e063-6394a90a56bd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glimepiride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA077091
- Marketing category
- ANDA
- Marketing start
- 2014-07-21
- 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, 199246, 199247 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68084-788-25 | Glimepiride | 30 in 1 BOX, UNIT-DOSE | TABLET | 30 | | 11 |
| 68084-788-95 | Glimepiride | 1 in 1 BLISTER PACK | TABLET | 1 | | 11 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-788 | GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING] | 11 | Current NDC, Legacy NDC, 2 package rows | 20241122_0003458f-352a-46fa-9d99-230daa76ae29.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 |
|---|
| 68084-788-25 | 68084078825 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-788-25) / 1 TABLET in 1 BLISTER PACK (68084-788-95) | 30 blister pack | 2016-01-19 | 0000-00-00 | No | No | Current |
| 68084-788-95 | 68084078895 | 1 in 1 BLISTER PACK | | | | | | Historical |