Glyburide-Metformin Hydrochloride
- Product NDC
- 10544-579
- 11-digit product format
- 105440579
- Labeler code
- 10544
- Product ID
- 10544-579_0f5e4bb2-193d-3a95-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glyburide-Metformin Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA079009
- Marketing category
- ANDA
- Marketing start
- 2013-12-20
- 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 |
|---|
| 10544-579-30 | Glyburide-Metformin Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 10544-579-90 | Glyburide-Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GLYBURIDE | ACTIVE INGREDIENT | SX6K58TVWC | GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| METFORMIN HYDROCHLORIDE | ACTIVE INGREDIENT | 786Z46389E | GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| GLYBURIDE | ACTIVE MOIETY | SX6K58TVWC | GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| METFORMIN | ACTIVE MOIETY | 9100L32L2N | GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| PROPYLENE GLYCOL, (R)- | INACTIVE INGREDIENT | 602HN5L69H | GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-579 | GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | Legacy NDC, 2 package rows | 20150218_0f530fcd-0ac0-3885-e054-00144ff88e88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-579-30 | 10544057930 | 30 in 1 BOTTLE | Historical |
| 10544-579-90 | 10544057990 | 90 in 1 BOTTLE | Historical |