Glyburide-Metformin Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Blenheim Pharmacal, Inc.. The primary component is Glyburide; Metformin Hydrochloride.
| Product ID | 10544-580_0f5e4bb2-193d-3a95-e054-00144ff8d46c |
| NDC | 10544-580 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Glyburide-Metformin Hydrochloride |
| Generic Name | Glyburide-metformin Hydrochloride |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2013-12-20 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA079009 |
| Labeler Name | Blenheim Pharmacal, Inc. |
| Substance Name | GLYBURIDE; METFORMIN HYDROCHLORIDE |
| Active Ingredient Strength | 3 mg/1; mg/1 |
| Pharm Classes | Sulfonylurea [EPC],Sulfonylurea Compounds [CS],Biguanide [EPC],Biguanides [CS] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
| Marketing Start Date | 2013-12-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA079009 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2013-12-20 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA079009 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2013-12-20 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| GLYBURIDE | 2.5 mg/1 |
| SPL SET ID: | 0f530fcd-0ac0-3885-e054-00144ff88e88 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 10544-579 | Glyburide-Metformin Hydrochloride | Glyburide-Metformin Hydrochloride |
| 10544-580 | Glyburide-Metformin Hydrochloride | Glyburide-Metformin Hydrochloride |
| 23155-233 | glyburide-metformin hydrochloride | glyburide-metformin hydrochloride |
| 23155-234 | glyburide-metformin hydrochloride | glyburide-metformin hydrochloride |
| 23155-235 | glyburide-metformin hydrochloride | glyburide-metformin hydrochloride |