glyburide and metformin hydrochloride

Generic: glyburide and metformin hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glyburide and metformin hydrochloride
Generic Name glyburide and metformin hydrochloride
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-0967
Product ID 71335-0967_a65ff15e-5686-4b04-87fa-234c40271d6a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077870
Listing Expiration 2026-12-31
Marketing Start 2007-11-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713350967
Hyphenated Format 71335-0967

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 and metformin hydrochloride (source: ndc)
Generic Name glyburide and metformin hydrochloride (source: ndc)
Application Number ANDA077870 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71335-0967-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71335-0967-3)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71335-0967-4)
  • 120 TABLET, FILM COATED in 1 BOTTLE (71335-0967-5)
  • 100 TABLET, FILM COATED in 1 BOTTLE (71335-0967-6)
  • 180 TABLET, FILM COATED in 1 BOTTLE (71335-0967-7)
  • 25 TABLET, FILM COATED in 1 BOTTLE (71335-0967-8)
source: ndc

Packages (7)

71335-0967-1 30 TABLET, FILM COATED in 1 BOTTLE (71335-0967-1) 71335-0967-3 60 TABLET, FILM COATED in 1 BOTTLE (71335-0967-3) 71335-0967-4 90 TABLET, FILM COATED in 1 BOTTLE (71335-0967-4) 71335-0967-5 120 TABLET, FILM COATED in 1 BOTTLE (71335-0967-5) 71335-0967-6 100 TABLET, FILM COATED in 1 BOTTLE (71335-0967-6) 71335-0967-7 180 TABLET, FILM COATED in 1 BOTTLE (71335-0967-7) 71335-0967-8 25 TABLET, FILM COATED in 1 BOTTLE (71335-0967-8)

Ingredients (2)

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

Linked Drug Pages (1)

Glyburide and Metformin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a65ff15e-5686-4b04-87fa-234c40271d6a", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["SX6K58TVWC", "786Z46389E"], "rxcui": ["861753"], "spl_set_id": ["8f2951ab-20c3-4216-b250-4c6a62d32203"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71335-0967-1)", "package_ndc": "71335-0967-1", "marketing_start_date": "20181015"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71335-0967-3)", "package_ndc": "71335-0967-3", "marketing_start_date": "20181015"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71335-0967-4)", "package_ndc": "71335-0967-4", "marketing_start_date": "20240530"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (71335-0967-5)", "package_ndc": "71335-0967-5", "marketing_start_date": "20240530"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (71335-0967-6)", "package_ndc": "71335-0967-6", "marketing_start_date": "20181011"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (71335-0967-7)", "package_ndc": "71335-0967-7", "marketing_start_date": "20240530"}, {"sample": false, "description": "25 TABLET, FILM COATED in 1 BOTTLE (71335-0967-8)", "package_ndc": "71335-0967-8", "marketing_start_date": "20240530"}], "brand_name": "Glyburide and Metformin Hydrochloride", "product_id": "71335-0967_a65ff15e-5686-4b04-87fa-234c40271d6a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "71335-0967", "generic_name": "Glyburide and Metformin Hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glyburide and Metformin Hydrochloride", "active_ingredients": [{"name": "GLYBURIDE", "strength": "5 mg/1"}, {"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA077870", "marketing_category": "ANDA", "marketing_start_date": "20071114", "listing_expiration_date": "20261231"}