glyburide-metformin hydrochloride

Generic: glyburide-metformin hydrochloride

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glyburide-metformin hydrochloride
Generic Name glyburide-metformin hydrochloride
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glyburide 5 mg/1, metformin hydrochloride 500 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8791
Product ID 68788-8791_d7d4d255-6028-4047-8907-75469f545f87
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079009
Listing Expiration 2027-12-31
Marketing Start 2024-12-17

Pharmacologic Class

Established (EPC)
sulfonylurea [epc]
Chemical Structure
sulfonylurea compounds [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888791
Hyphenated Format 68788-8791

Supplemental Identifiers

RxCUI
861753
UNII
SX6K58TVWC 786Z46389E
NUI
N0000175608 M0020795

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name glyburide-metformin hydrochloride (source: ndc)
Generic Name glyburide-metformin hydrochloride (source: ndc)
Application Number ANDA079009 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68788-8791-1)
  • 30 TABLET in 1 BOTTLE (68788-8791-3)
  • 60 TABLET in 1 BOTTLE (68788-8791-6)
  • 120 TABLET in 1 BOTTLE (68788-8791-8)
  • 90 TABLET in 1 BOTTLE (68788-8791-9)
source: ndc

Packages (5)

68788-8791-1 100 TABLET in 1 BOTTLE (68788-8791-1) 68788-8791-3 30 TABLET in 1 BOTTLE (68788-8791-3) 68788-8791-6 60 TABLET in 1 BOTTLE (68788-8791-6) 68788-8791-8 120 TABLET in 1 BOTTLE (68788-8791-8) 68788-8791-9 90 TABLET in 1 BOTTLE (68788-8791-9)

Ingredients (2)

glyburide (5 mg/1) metformin hydrochloride (500 mg/1)

Linked Drug Pages (1)

glyburide-metformin hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d7d4d255-6028-4047-8907-75469f545f87", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["SX6K58TVWC", "786Z46389E"], "rxcui": ["861753"], "spl_set_id": ["a0ff8ee6-0da8-40f8-b5b0-a7b334e1a15f"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68788-8791-1)", "package_ndc": "68788-8791-1", "marketing_start_date": "20241217"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8791-3)", "package_ndc": "68788-8791-3", "marketing_start_date": "20241217"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-8791-6)", "package_ndc": "68788-8791-6", "marketing_start_date": "20241217"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (68788-8791-8)", "package_ndc": "68788-8791-8", "marketing_start_date": "20241217"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8791-9)", "package_ndc": "68788-8791-9", "marketing_start_date": "20241217"}], "brand_name": "glyburide-metformin hydrochloride", "product_id": "68788-8791_d7d4d255-6028-4047-8907-75469f545f87", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "68788-8791", "generic_name": "glyburide-metformin hydrochloride", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "glyburide-metformin hydrochloride", "active_ingredients": [{"name": "GLYBURIDE", "strength": "5 mg/1"}, {"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA079009", "marketing_category": "ANDA", "marketing_start_date": "20241217", "listing_expiration_date": "20271231"}