Glimepiride
- Product NDC
- 70518-4485
- 11-digit product format
- 705184485
- Labeler code
- 70518
- Product ID
- 70518-4485_42ed41d4-9928-5342-e063-6394a90af67e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glimepiride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA202112
- Marketing category
- ANDA
- Marketing start
- 2025-09-28
- Substance
- GLIMEPIRIDE
- Active strength
- 4 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 | 4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6KY687524K |
| Rxcui | 199247 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4485-0 | Glimepiride | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 3 |
| 70518-4485-1 | Glimepiride | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 3 |
| 70518-4485-2 | Glimepiride | 30 in 1 BLISTER PACK | TABLET | 30 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4485-0 | 70518448500 | 100 TABLET in 1 BOTTLE, PLASTIC (70518-4485-0) | 100 tablet | 2025-09-28 | No | No | Historical |
| 70518-4485-1 | 70518448501 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-4485-1) | 90 tablet | 2025-10-03 | No | No | Historical |
| 70518-4485-2 | 70518448502 | 30 TABLET in 1 BLISTER PACK (70518-4485-2) | 30 tablet | 2025-11-05 | No | No | Historical |