glyburide and metformin hydrochloride (50090-0887)

Drug Facts

Product Profile

Brand Name glyburide and metformin hydrochloride

Generic Name glyburide and metformin hydrochloride

Labeler a-s medication solutions

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

glyburide 2.5 mg/1, metformin hydrochloride 500 mg/1

Manufacturer

A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-0887

Product ID 50090-0887_0797d374-f582-4573-8a17-8d55185be64d

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 500900887

Hyphenated Format 50090-0887

Supplemental Identifiers

RxCUI

861748

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

2.5 mg/1
500 mg/1

source: ndc

Packaging

60 TABLET, FILM COATED in 1 BOTTLE (50090-0887-0)
30 TABLET, FILM COATED in 1 BOTTLE (50090-0887-1)
180 TABLET, FILM COATED in 1 BOTTLE (50090-0887-2)
90 TABLET, FILM COATED in 1 BOTTLE (50090-0887-3)

source: ndc

Packages (4)

50090-0887-0 60 TABLET, FILM COATED in 1 BOTTLE (50090-0887-0) 50090-0887-1 30 TABLET, FILM COATED in 1 BOTTLE (50090-0887-1) 50090-0887-2 180 TABLET, FILM COATED in 1 BOTTLE (50090-0887-2) 50090-0887-3 90 TABLET, FILM COATED in 1 BOTTLE (50090-0887-3)

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": "0797d374-f582-4573-8a17-8d55185be64d", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["SX6K58TVWC", "786Z46389E"], "rxcui": ["861748"], "spl_set_id": ["ea6a2324-486d-4c7f-88ec-2b4abf5dc5b4"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (50090-0887-0)", "package_ndc": "50090-0887-0", "marketing_start_date": "20141128"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-0887-1)", "package_ndc": "50090-0887-1", "marketing_start_date": "20191009"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (50090-0887-2)", "package_ndc": "50090-0887-2", "marketing_start_date": "20141128"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-0887-3)", "package_ndc": "50090-0887-3", "marketing_start_date": "20191009"}], "brand_name": "Glyburide and Metformin Hydrochloride", "product_id": "50090-0887_0797d374-f582-4573-8a17-8d55185be64d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "50090-0887", "generic_name": "Glyburide and Metformin Hydrochloride", "labeler_name": "A-S Medication Solutions", "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"}