glipizide and metformin hydrochloride

Generic: glipizide and metformin hydrochloride

Labeler: zydus lifesciences limited
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 zydus lifesciences limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

glipizide 2.5 mg/1, metformin hydrochloride 250 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 65841-659
Product ID 65841-659_62c55ebc-1883-4bfb-a772-2614c99a2fec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078905
Listing Expiration 2026-12-31
Marketing Start 2016-05-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65841659
Hyphenated Format 65841-659

Supplemental Identifiers

RxCUI
861731 861736 861740
UNII
X7WDT95N5C 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 glipizide and metformin hydrochloride (source: ndc)
Generic Name glipizide and metformin hydrochloride (source: ndc)
Application Number ANDA078905 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
  • 250 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65841-659-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65841-659-10)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65841-659-16)
  • 10 BLISTER PACK in 1 CARTON (65841-659-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-659-30)
source: ndc

Packages (4)

65841-659-01 100 TABLET, FILM COATED in 1 BOTTLE (65841-659-01) 65841-659-10 1000 TABLET, FILM COATED in 1 BOTTLE (65841-659-10) 65841-659-16 90 TABLET, FILM COATED in 1 BOTTLE (65841-659-16) 65841-659-77 10 BLISTER PACK in 1 CARTON (65841-659-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-659-30)

Ingredients (2)

glipizide (2.5 mg/1) metformin hydrochloride (250 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": "62c55ebc-1883-4bfb-a772-2614c99a2fec", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["X7WDT95N5C", "786Z46389E"], "rxcui": ["861731", "861736", "861740"], "spl_set_id": ["bd2e1c06-424b-4222-b723-90ffdcc3983c"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65841-659-01)", "package_ndc": "65841-659-01", "marketing_start_date": "20160505"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65841-659-10)", "package_ndc": "65841-659-10", "marketing_start_date": "20160505"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65841-659-16)", "package_ndc": "65841-659-16", "marketing_start_date": "20160505"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65841-659-77)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-659-30)", "package_ndc": "65841-659-77", "marketing_start_date": "20160505"}], "brand_name": "Glipizide and Metformin Hydrochloride", "product_id": "65841-659_62c55ebc-1883-4bfb-a772-2614c99a2fec", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "65841-659", "generic_name": "Glipizide and Metformin Hydrochloride", "labeler_name": "Zydus Lifesciences Limited", "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": "250 mg/1"}], "application_number": "ANDA078905", "marketing_category": "ANDA", "marketing_start_date": "20160505", "listing_expiration_date": "20261231"}