Glimepiride
- Product NDC
- 66116-432
- 11-digit product format
- 661160432
- Labeler code
- 66116
- Product ID
- 66116-432_3f626e54-b043-4556-9568-ace556cff9e9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glimepiride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- MedVantx, Inc.
- Application
- ANDA076802
- Marketing category
- ANDA
- Marketing start
- 2012-04-19
- Marketing end
- 0000-00-00
- Substance
- GLIMEPIRIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66116-432-30 | Glimepiride | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GLIMEPIRIDE | ACTIVE INGREDIENT | 6KY687524K | GLIMEPIRIDE TABLET [MEDVANTX, INC.] | 1 | |
| GLIMEPIRIDE | ACTIVE MOIETY | 6KY687524K | GLIMEPIRIDE TABLET [MEDVANTX, INC.] | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | GLIMEPIRIDE TABLET [MEDVANTX, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GLIMEPIRIDE TABLET [MEDVANTX, INC.] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | GLIMEPIRIDE TABLET [MEDVANTX, INC.] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | GLIMEPIRIDE TABLET [MEDVANTX, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | GLIMEPIRIDE TABLET [MEDVANTX, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GLIMEPIRIDE TABLET [MEDVANTX, INC.] | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | GLIMEPIRIDE TABLET [MEDVANTX, INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | GLIMEPIRIDE TABLET [MEDVANTX, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66116-432 | GLIMEPIRIDE TABLET [MEDVANTX, INC.] | 1 | Legacy NDC, 1 package rows | 20120710_3f626e54-b043-4556-9568-ace556cff9e9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 66116-432-30 | 66116043230 | 30 in 1 BOTTLE | Historical |