Glyburide and Metformin Hydrochloride
- Product NDC
- 67544-511
- 11-digit product format
- 675440511
- Labeler code
- 67544
- Product ID
- 67544-511_4cb7dc91-6c9a-4feb-b2aa-7b4724e9f681
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glyburide and Metformin Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, Inc.
- Application
- ANDA076716
- Marketing category
- ANDA
- Marketing start
- 2005-06-28
- Marketing end
- 0000-00-00
- Substance
- GLYBURIDE; METFORMIN HYDROCHLORIDE
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Sulfonylurea [EPC],Sulfonylurea Compounds [CS],Biguanide [EPC],Biguanides [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 |
|---|
| 67544-511-70 | Glyburide and Metformin Hydrochloride | 120 in 1 BOTTLE, PLASTIC | TABLET | 120 | | 1 |
| 67544-511-94 | Glyburide and Metformin Hydrochloride | 360 in 1 BOTTLE, PLASTIC | TABLET | 360 | | 1 |
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 Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67544-511 | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | Legacy NDC, 2 package rows | 20120829_da18895f-5145-4b4d-a2a4-4ba9498e237e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 67544-511-70 | 67544051170 | 120 in 1 BOTTLE, PLASTIC | Historical |
| 67544-511-94 | 67544051194 | 360 in 1 BOTTLE, PLASTIC | Historical |