Glimepiride
- Product NDC
- 63187-486
- 11-digit product format
- 631870486
- Labeler code
- 63187
- Product ID
- 63187-486_d49136d3-d03e-4ed6-88ab-05cce831e7fe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glimepiride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA078181
- Marketing category
- ANDA
- Marketing start
- 2007-08-23
- 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 |
|---|
| 63187-486-30 | Glimepiride | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
| 63187-486-60 | Glimepiride | 60 in 1 BOTTLE | TABLET | 60 | | 6 |
| 63187-486-90 | Glimepiride | 90 in 1 BOTTLE | TABLET | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-486 | GLIMEPIRIDE TABLET [PROFICIENT RX LP] | 6 | Current NDC, Legacy NDC, 3 package rows | 20220507_68cb4fcd-5bc3-4f53-9085-86df6a4246d6.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 |
|---|
| 63187-486-30 | 63187048630 | 30 TABLET in 1 BOTTLE (63187-486-30) | 30 tablet | 2015-02-02 | 0000-00-00 | No | No | Current |
| 63187-486-60 | 63187048660 | 60 TABLET in 1 BOTTLE (63187-486-60) | 60 tablet | 2015-02-02 | 0000-00-00 | No | No | Current |
| 63187-486-90 | 63187048690 | 90 TABLET in 1 BOTTLE (63187-486-90) | 90 tablet | 2022-04-01 | 0000-00-00 | No | No | Current |