glipizide and metformin hydrochloride

Generic: glipizide and metformin hydrochloride

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glipizide and metformin hydrochloride
Generic Name glipizide and metformin hydrochloride
Labeler avkare
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-305
Product ID 42291-305_4122e328-9fc7-2590-e063-6394a90a37bd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077270
Listing Expiration 2026-12-31
Marketing Start 2013-07-08

Pharmacologic Class

Established (EPC)
sulfonylurea [epc]
Chemical Structure
sulfonylurea compounds [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291305
Hyphenated Format 42291-305

Supplemental Identifiers

RxCUI
861736 861740
UPC
0342291305014 0342291306011
UNII
X7WDT95N5C 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 glipizide and metformin hydrochloride (source: ndc)
Generic Name glipizide and metformin hydrochloride (source: ndc)
Application Number ANDA077270 (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 (42291-305-01)
source: ndc

Packages (1)

42291-305-01 100 TABLET, FILM COATED in 1 BOTTLE (42291-305-01)

Ingredients (2)

glipizide (2.5 mg/1) metformin hydrochloride (500 mg/1)

Linked Drug Pages (1)

Glipizide and Metformin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4122e328-9fc7-2590-e063-6394a90a37bd", "openfda": {"nui": ["N0000175608", "M0020795"], "upc": ["0342291305014", "0342291306011"], "unii": ["X7WDT95N5C", "786Z46389E"], "rxcui": ["861736", "861740"], "spl_set_id": ["13be49d2-0ce9-a78a-e557-ded85ddc808f"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (42291-305-01)", "package_ndc": "42291-305-01", "marketing_start_date": "20130708"}], "brand_name": "Glipizide and Metformin Hydrochloride", "product_id": "42291-305_4122e328-9fc7-2590-e063-6394a90a37bd", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "42291-305", "generic_name": "Glipizide and Metformin Hydrochloride", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glipizide and Metformin Hydrochloride", "active_ingredients": [{"name": "GLIPIZIDE", "strength": "2.5 mg/1"}, {"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA077270", "marketing_category": "ANDA", "marketing_start_date": "20130708", "listing_expiration_date": "20261231"}