glyburide and metformin hydrochloride (65862-082)

Drug Facts

Product Profile

Brand Name glyburide and metformin hydrochloride

Generic Name glyburide and metformin hydrochloride

Labeler aurobindo pharma limited

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

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

Manufacturer

Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-082

Product ID 65862-082_70d68bf1-dadf-47e4-8070-2897ee4f7c8b

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 65862082

Hyphenated Format 65862-082

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 ANDA077870 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1
500 mg/1

source: ndc

Packaging

100 TABLET, FILM COATED in 1 BOTTLE (65862-082-01)
500 TABLET, FILM COATED in 1 BOTTLE (65862-082-05)
30 TABLET, FILM COATED in 1 BOTTLE (65862-082-30)

source: ndc

Packages (3)

65862-082-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-082-01) 65862-082-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-082-05) 65862-082-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-082-30)

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": "70d68bf1-dadf-47e4-8070-2897ee4f7c8b", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["SX6K58TVWC", "786Z46389E"], "rxcui": ["861743", "861748", "861753"], "spl_set_id": ["7010b662-8b34-49ce-8e5b-73dee0821a60"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65862-082-01)", "package_ndc": "65862-082-01", "marketing_start_date": "20071114"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-082-05)", "package_ndc": "65862-082-05", "marketing_start_date": "20071114"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-082-30)", "package_ndc": "65862-082-30", "marketing_start_date": "20071114"}], "brand_name": "Glyburide and Metformin Hydrochloride", "product_id": "65862-082_70d68bf1-dadf-47e4-8070-2897ee4f7c8b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "65862-082", "generic_name": "Glyburide and Metformin Hydrochloride", "labeler_name": "Aurobindo Pharma 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": "ANDA077870", "marketing_category": "ANDA", "marketing_start_date": "20071114", "listing_expiration_date": "20261231"}