glyburide-metformin hydrochloride

Generic: glyburide-metformin hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glyburide-metformin hydrochloride
Generic Name glyburide-metformin hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7814
Product ID 50090-7814_16b2602c-1227-49a6-b7fa-ee94c31bb05e
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 500907814
Hyphenated Format 50090-7814

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-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
  • 60 TABLET in 1 BOTTLE (50090-7814-0)
  • 180 TABLET in 1 BOTTLE (50090-7814-2)
source: ndc

Packages (2)

50090-7814-0 60 TABLET in 1 BOTTLE (50090-7814-0) 50090-7814-2 180 TABLET in 1 BOTTLE (50090-7814-2)

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": "16b2602c-1227-49a6-b7fa-ee94c31bb05e", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["SX6K58TVWC", "786Z46389E"], "rxcui": ["861748"], "spl_set_id": ["faa19e1b-2782-4bf1-a93f-84755f7aa53f"], "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 in 1 BOTTLE (50090-7814-0)", "package_ndc": "50090-7814-0", "marketing_start_date": "20251209"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (50090-7814-2)", "package_ndc": "50090-7814-2", "marketing_start_date": "20251209"}], "brand_name": "glyburide-metformin hydrochloride", "product_id": "50090-7814_16b2602c-1227-49a6-b7fa-ee94c31bb05e", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "50090-7814", "generic_name": "glyburide-metformin hydrochloride", "labeler_name": "A-S Medication Solutions", "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"}