Glyburide and Metformin Hydrochloride
- Product NDC
- 57237-025
- 11-digit product format
- 572370025
- Labeler code
- 57237
- Product ID
- 57237-025_ca40b2d8-0009-46d0-9be4-64edd26b390b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glyburide and Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA077870
- Marketing category
- ANDA
- Marketing start
- 2007-11-14
- Substance
- GLYBURIDE; METFORMIN HYDROCHLORIDE
- Active strength
- 5; 500 mg/1; mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS], 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
- Glyburide and Metformin Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLYBURIDE | 5 mg/1 |
| METFORMIN HYDROCHLORIDE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SX6K58TVWC, 786Z46389E |
| Rxcui | 861743, 861748, 861753 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57237-025-01 | Glyburide and Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 10 |
| 57237-025-05 | Glyburide and Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GLYBURIDE | ACTIVE INGREDIENT | SX6K58TVWC | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| METFORMIN HYDROCHLORIDE | ACTIVE INGREDIENT | 786Z46389E | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| GLYBURIDE | ACTIVE MOIETY | SX6K58TVWC | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| METFORMIN | ACTIVE MOIETY | 9100L32L2N | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| POVIDONE K90 | INACTIVE INGREDIENT | RDH86HJV5Z | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57237-025 | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240515_372af566-d6ec-446f-88db-0b4cc83b577f.zip |
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 |
|---|
| 57237-025-01 | 57237002501 | 100 TABLET, FILM COATED in 1 BOTTLE (57237-025-01) | 2007-11-14 | 0000-00-00 | No | No | Current |
| 57237-025-05 | 57237002505 | 500 TABLET, FILM COATED in 1 BOTTLE (57237-025-05) | 2007-11-14 | 0000-00-00 | No | No | Current |