NDC 10544-579

Glyburide-Metformin Hydrochloride

Glyburide-metformin Hydrochloride

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: 10544-579_0f5e4bb2-193d-3a95-e054-00144ff8d46c
• NDC: 10544-579
• 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: 5 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

Packaging

NDC 10544-579-90

90 TABLET in 1 BOTTLE (10544-579-90)

• Marketing Start Date: 2013-12-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10544-579-30 [10544057930]

Glyburide-Metformin Hydrochloride TABLET

• Marketing Category: ANDA
• Application Number: ANDA079009
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-12-20
• Inactivation Date: 2020-01-31

NDC 10544-579-90 [10544057990]

Glyburide-Metformin Hydrochloride TABLET

• Marketing Category: ANDA
• Application Number: ANDA079009
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-12-20
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
GLYBURIDE	5 mg/1

OpenFDA Data

• SPL SET ID: 0f530fcd-0ac0-3885-e054-00144ff88e88
• Manufacturer:
  • Blenheim Pharmacal, Inc.
• UNII:
  • SX6K58TVWC
  • 786Z46389E
• RxNorm Concept Unique ID - RxCUI:
  • 861753
  • 861748

Pharmacological Class

• Sulfonylurea [EPC]
• Sulfonylurea Compounds [CS]
• Biguanide [EPC]
• Biguanides [CS]

NDC Crossover Matching brand name "Glyburide-Metformin Hydrochloride" or generic name "Glyburide-metformin Hydrochloride"

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