glyburide and metformin hydrochloride (65862-081)

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 2.5 mg/1, metformin hydrochloride 500 mg/1

Manufacturer

Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-081

Product ID 65862-081_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 65862081

Hyphenated Format 65862-081

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

2.5 mg/1
500 mg/1

source: ndc

Packaging

100 TABLET, FILM COATED in 1 BOTTLE (65862-081-01)
500 TABLET, FILM COATED in 1 BOTTLE (65862-081-05)
30 TABLET, FILM COATED in 1 BOTTLE (65862-081-30)

source: ndc

Packages (3)

65862-081-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-081-01) 65862-081-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-081-05) 65862-081-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-081-30)

Ingredients (2)

glyburide (2.5 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 (65862-081-01)", "package_ndc": "65862-081-01", "marketing_start_date": "20071114"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-081-05)", "package_ndc": "65862-081-05", "marketing_start_date": "20071114"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-081-30)", "package_ndc": "65862-081-30", "marketing_start_date": "20071114"}], "brand_name": "Glyburide and Metformin Hydrochloride", "product_id": "65862-081_70d68bf1-dadf-47e4-8070-2897ee4f7c8b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "65862-081", "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": "2.5 mg/1"}, {"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA077870", "marketing_category": "ANDA", "marketing_start_date": "20071114", "listing_expiration_date": "20261231"}