glyburide and metformin hydrochloride

Generic: glyburide and metformin hydrochloride

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

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 50090-2031
Product ID 50090-2031_4ec075ec-85cf-451e-927a-80ab73d2a2d7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077870
Listing Expiration 2027-12-31
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 500902031
Hyphenated Format 50090-2031

Supplemental Identifiers

RxCUI
861748 861753
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 (50090-2031-0)
  • 180 TABLET, FILM COATED in 1 BOTTLE (50090-2031-2)
source: ndc

Packages (2)

50090-2031-0 60 TABLET, FILM COATED in 1 BOTTLE (50090-2031-0) 50090-2031-2 180 TABLET, FILM COATED in 1 BOTTLE (50090-2031-2)

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": "4ec075ec-85cf-451e-927a-80ab73d2a2d7", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["SX6K58TVWC", "786Z46389E"], "rxcui": ["861748", "861753"], "spl_set_id": ["d87dade1-55fe-4e77-91b9-b642022a2b8a"], "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 (50090-2031-0)", "package_ndc": "50090-2031-0", "marketing_start_date": "20150924"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (50090-2031-2)", "package_ndc": "50090-2031-2", "marketing_start_date": "20150924"}], "brand_name": "Glyburide and Metformin Hydrochloride", "product_id": "50090-2031_4ec075ec-85cf-451e-927a-80ab73d2a2d7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "50090-2031", "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": "20271231"}