Glimepiride
- Product NDC
- 16729-002
- 11-digit product format
- 167290002
- Labeler code
- 16729
- Product ID
- 16729-002_415deb6c-47dc-ed2a-e063-6394a90a66fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glimepiride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Accord Healthcare Inc
- Application
- ANDA078181
- Marketing category
- ANDA
- Marketing start
- 2007-08-23
- 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 |
|---|
| 16729-002-01 | Glimepiride | 100 in 1 BOTTLE | TABLET | 100 | | 10 |
| 16729-002-16 | Glimepiride | 500 in 1 BOTTLE | TABLET | 500 | | 10 |
| 16729-002-17 | Glimepiride | 1000 in 1 BOTTLE | TABLET | 1000 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GLIMEPIRIDE | ACTIVE INGREDIENT | 6KY687524K | GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| GLIMEPIRIDE | ACTIVE MOIETY | 6KY687524K | GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| GLIMEPIRIDE | ACTIVE INGREDIENT | 6KY687524K | GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC] | 4 | |
| GLIMEPIRIDE | ACTIVE MOIETY | 6KY687524K | GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC] | 4 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC] | 4 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC] | 4 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC] | 4 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC] | 4 | |
| GLIMEPIRIDE | ACTIVE INGREDIENT | 6KY687524K | GLIMEPIRIDE TABLET [DIRECTRX] | 1 | |
| GLIMEPIRIDE | ACTIVE MOIETY | 6KY687524K | GLIMEPIRIDE TABLET [DIRECTRX] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | GLIMEPIRIDE TABLET [DIRECTRX] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | GLIMEPIRIDE TABLET [DIRECTRX] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | GLIMEPIRIDE TABLET [DIRECTRX] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GLIMEPIRIDE TABLET [DIRECTRX] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | GLIMEPIRIDE TABLET [DIRECTRX] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | GLIMEPIRIDE TABLET [DIRECTRX] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-002 | GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC] | 9 | Current NDC, Legacy NDC, 3 package rows | 20231129_9b74fbac-9e04-4927-9981-1e3dace89c6d.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 |
|---|
| 16729-002-01 | 16729000201 | 100 TABLET in 1 BOTTLE (16729-002-01) | 100 tablet | 2007-08-23 | 0000-00-00 | No | No | Current |
| 16729-002-16 | 16729000216 | 500 TABLET in 1 BOTTLE (16729-002-16) | 500 tablet | 2016-08-24 | 0000-00-00 | No | No | Current |
| 16729-002-17 | 16729000217 | 1000 in 1 BOTTLE | | | | | | Historical |