glyburide-metformin hydrochloride (23155-234)

Drug Facts

Product Profile

Brand Name glyburide-metformin hydrochloride

Generic Name glyburide-metformin hydrochloride

Labeler heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 23155-234

Product ID 23155-234_d1986b8d-2976-4795-8c57-46322585b2b5

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 23155234

Hyphenated Format 23155-234

Supplemental Identifiers

RxCUI

861743 861748 861753

UPC

0323155235012 0323155233018 0323155234015

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-metformin hydrochloride (source: ndc)

Generic Name glyburide-metformin hydrochloride (source: ndc)

Application Number ANDA079009 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

2.5 mg/1
500 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (23155-234-01)
500 TABLET in 1 BOTTLE (23155-234-05)
1000 TABLET in 1 BOTTLE (23155-234-10)

source: ndc

Packages (3)

23155-234-01 100 TABLET in 1 BOTTLE (23155-234-01) 23155-234-05 500 TABLET in 1 BOTTLE (23155-234-05) 23155-234-10 1000 TABLET in 1 BOTTLE (23155-234-10)

Ingredients (2)

glyburide (2.5 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": "d1986b8d-2976-4795-8c57-46322585b2b5", "openfda": {"nui": ["N0000175608", "M0020795"], "upc": ["0323155235012", "0323155233018", "0323155234015"], "unii": ["SX6K58TVWC", "786Z46389E"], "rxcui": ["861743", "861748", "861753"], "spl_set_id": ["b38213bb-d663-4c95-a1b2-96c23ee5be09"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (23155-234-01)", "package_ndc": "23155-234-01", "marketing_start_date": "20240501"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (23155-234-05)", "package_ndc": "23155-234-05", "marketing_start_date": "20240501"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (23155-234-10)", "package_ndc": "23155-234-10", "marketing_start_date": "20240501"}], "brand_name": "glyburide-metformin hydrochloride", "product_id": "23155-234_d1986b8d-2976-4795-8c57-46322585b2b5", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "23155-234", "generic_name": "glyburide-metformin hydrochloride", "labeler_name": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "glyburide-metformin hydrochloride", "active_ingredients": [{"name": "GLYBURIDE", "strength": "2.5 mg/1"}, {"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA079009", "marketing_category": "ANDA", "marketing_start_date": "20240501", "listing_expiration_date": "20261231"}