glyburide-metformin hydrochloride

Generic: glyburide-metformin hydrochloride

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

Drug Facts

Product Profile

Brand Name glyburide-metformin hydrochloride
Generic Name glyburide-metformin hydrochloride
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-2508
Product ID 71335-2508_e2fae12e-8044-43ad-994d-70ca0ad42174
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079009
Listing Expiration 2026-12-31
Marketing Start 2024-05-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713352508
Hyphenated Format 71335-2508

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
  • 30 TABLET in 1 BOTTLE (71335-2508-1)
  • 60 TABLET in 1 BOTTLE (71335-2508-3)
  • 90 TABLET in 1 BOTTLE (71335-2508-4)
  • 120 TABLET in 1 BOTTLE (71335-2508-5)
  • 100 TABLET in 1 BOTTLE (71335-2508-6)
  • 180 TABLET in 1 BOTTLE (71335-2508-7)
  • 25 TABLET in 1 BOTTLE (71335-2508-8)
source: ndc

Packages (7)

71335-2508-1 30 TABLET in 1 BOTTLE (71335-2508-1) 71335-2508-3 60 TABLET in 1 BOTTLE (71335-2508-3) 71335-2508-4 90 TABLET in 1 BOTTLE (71335-2508-4) 71335-2508-5 120 TABLET in 1 BOTTLE (71335-2508-5) 71335-2508-6 100 TABLET in 1 BOTTLE (71335-2508-6) 71335-2508-7 180 TABLET in 1 BOTTLE (71335-2508-7) 71335-2508-8 25 TABLET in 1 BOTTLE (71335-2508-8)

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": "e2fae12e-8044-43ad-994d-70ca0ad42174", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["SX6K58TVWC", "786Z46389E"], "rxcui": ["861753"], "spl_set_id": ["b5ccf5da-cbe1-4009-ba1c-990050838ee9"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71335-2508-1)", "package_ndc": "71335-2508-1", "marketing_start_date": "20241021"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71335-2508-3)", "package_ndc": "71335-2508-3", "marketing_start_date": "20241021"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71335-2508-4)", "package_ndc": "71335-2508-4", "marketing_start_date": "20241021"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71335-2508-5)", "package_ndc": "71335-2508-5", "marketing_start_date": "20241021"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (71335-2508-6)", "package_ndc": "71335-2508-6", "marketing_start_date": "20241021"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71335-2508-7)", "package_ndc": "71335-2508-7", "marketing_start_date": "20241021"}, {"sample": false, "description": "25 TABLET in 1 BOTTLE (71335-2508-8)", "package_ndc": "71335-2508-8", "marketing_start_date": "20241021"}], "brand_name": "glyburide-metformin hydrochloride", "product_id": "71335-2508_e2fae12e-8044-43ad-994d-70ca0ad42174", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "71335-2508", "generic_name": "glyburide-metformin hydrochloride", "labeler_name": "Bryant Ranch Prepack", "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": "20240501", "listing_expiration_date": "20261231"}