Glyburide and Metformin Hydrochloride
- Product NDC
- 0228-2753
- 11-digit product format
- 002282753
- Labeler code
- 0228
- Product ID
- 0228-2753_558bd059-6925-46f5-9132-ac6fde1ba07a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glyburide and Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA076716
- Marketing category
- ANDA
- Marketing start
- 2005-06-28
- Marketing end
- 2022-06-30
- Substance
- GLYBURIDE; METFORMIN HYDROCHLORIDE
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GLYBURIDE | ACTIVE INGREDIENT | SX6K58TVWC | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| METFORMIN HYDROCHLORIDE | ACTIVE INGREDIENT | 786Z46389E | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| GLYBURIDE | ACTIVE MOIETY | SX6K58TVWC | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| METFORMIN | ACTIVE MOIETY | 9100L32L2N | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) | INACTIVE INGREDIENT | 5KY68S2577 | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| SORBIC ACID | INACTIVE INGREDIENT | X045WJ989B | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0228-2753-11 | 00228275311 | 100 TABLET, FILM COATED in 1 BOTTLE (0228-2753-11) | 2005-06-28 | 0000-00-00 | No | No | Current |
| 0228-2753-50 | 00228275350 | 500 TABLET, FILM COATED in 1 BOTTLE (0228-2753-50) | 2005-06-28 | 0000-00-00 | No | No | Current |