glyburide and metformin hydrochloride

Generic: glyburide and metformin hydrochloride

Labeler: zydus lifesciences limited
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 zydus lifesciences limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 65841-826
Product ID 65841-826_74ad710f-2587-4697-a053-bf02d23fadcb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206748
Listing Expiration 2026-12-31
Marketing Start 2016-04-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65841826
Hyphenated Format 65841-826

Supplemental Identifiers

RxCUI
861743 861748 861753
UNII
SX6K58TVWC 786Z46389E
NUI
N0000175608 M0020795

Packaging Origin

Original Packager
true

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 ANDA206748 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (65841-826-01)
  • 500 TABLET in 1 BOTTLE (65841-826-05)
  • 30 TABLET in 1 BOTTLE (65841-826-06)
  • 1000 TABLET in 1 BOTTLE (65841-826-10)
  • 90 TABLET in 1 BOTTLE (65841-826-16)
  • 10 BLISTER PACK in 1 CARTON (65841-826-77) / 10 TABLET in 1 BLISTER PACK (65841-826-30)
source: ndc

Packages (6)

65841-826-01 100 TABLET in 1 BOTTLE (65841-826-01) 65841-826-05 500 TABLET in 1 BOTTLE (65841-826-05) 65841-826-06 30 TABLET in 1 BOTTLE (65841-826-06) 65841-826-10 1000 TABLET in 1 BOTTLE (65841-826-10) 65841-826-16 90 TABLET in 1 BOTTLE (65841-826-16) 65841-826-77 10 BLISTER PACK in 1 CARTON (65841-826-77) / 10 TABLET in 1 BLISTER PACK (65841-826-30)

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": "74ad710f-2587-4697-a053-bf02d23fadcb", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["SX6K58TVWC", "786Z46389E"], "rxcui": ["861743", "861748", "861753"], "spl_set_id": ["df752bd4-e197-40a4-a01b-d48ba2c10516"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (65841-826-01)", "package_ndc": "65841-826-01", "marketing_start_date": "20160407"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (65841-826-05)", "package_ndc": "65841-826-05", "marketing_start_date": "20160407"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (65841-826-06)", "package_ndc": "65841-826-06", "marketing_start_date": "20160407"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65841-826-10)", "package_ndc": "65841-826-10", "marketing_start_date": "20160407"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (65841-826-16)", "package_ndc": "65841-826-16", "marketing_start_date": "20160407"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65841-826-77)  / 10 TABLET in 1 BLISTER PACK (65841-826-30)", "package_ndc": "65841-826-77", "marketing_start_date": "20160407"}], "brand_name": "glyburide and metformin hydrochloride", "product_id": "65841-826_74ad710f-2587-4697-a053-bf02d23fadcb", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "65841-826", "generic_name": "glyburide and metformin hydrochloride", "labeler_name": "Zydus Lifesciences Limited", "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": "ANDA206748", "marketing_category": "ANDA", "marketing_start_date": "20160407", "listing_expiration_date": "20261231"}