Glimepiride
- Product NDC
- 61442-116
- 11-digit product format
- 614420116
- Labeler code
- 61442
- Product ID
- 61442-116_2386d706-9dab-4ae0-e063-6394a90a8a06
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glimepiride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Carlsbad Technology, Inc.
- Application
- ANDA077911
- Marketing category
- ANDA
- Marketing start
- 2012-01-01
- 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 |
|---|
| 61442-116-01 | Glimepiride | 100 in 1 BOTTLE | TABLET | 100 | | 11 |
| 61442-116-05 | Glimepiride | 500 in 1 BOTTLE | TABLET | 500 | | 11 |
| 61442-116-10 | Glimepiride | 1000 in 1 BOTTLE | TABLET | 1000 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GLIMEPIRIDE | ACTIVE INGREDIENT | 6KY687524K | GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| GLIMEPIRIDE | ACTIVE MOIETY | 6KY687524K | GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61442-116 | GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.] | 11 | Current NDC, Legacy NDC, 3 package rows | 20241004_72d88c6d-2f0a-4bf8-aa7f-1e1811794187.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 |
|---|
| 61442-116-01 | 61442011601 | 100 TABLET in 1 BOTTLE (61442-116-01) | 100 tablet | 2012-01-01 | 0000-00-00 | No | No | Current |
| 61442-116-05 | 61442011605 | 500 TABLET in 1 BOTTLE (61442-116-05) | 500 tablet | 2012-01-01 | 0000-00-00 | No | No | Current |
| 61442-116-10 | 61442011610 | 1000 TABLET in 1 BOTTLE (61442-116-10) | 1000 tablet | 2012-01-01 | 0000-00-00 | No | No | Current |