glipizide and metformin hydrochloride

Generic: glipizide and metformin hydrochloride

Labeler: zydus pharmaceuticals usa inc.
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 pharmaceuticals usa inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

glipizide 5 mg/1, metformin hydrochloride 500 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-186
Product ID 68382-186_cf07fef0-8b0c-4673-8a46-afbf1d21d0b7
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 68382186
Hyphenated Format 68382-186

Supplemental Identifiers

RxCUI
861731 861736 861740
UPC
0368382184016
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
  • 5 mg/1
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68382-186-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (68382-186-10)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68382-186-16)
  • 10 BLISTER PACK in 1 CARTON (68382-186-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-186-30)
source: ndc

Packages (4)

68382-186-01 100 TABLET, FILM COATED in 1 BOTTLE (68382-186-01) 68382-186-10 1000 TABLET, FILM COATED in 1 BOTTLE (68382-186-10) 68382-186-16 90 TABLET, FILM COATED in 1 BOTTLE (68382-186-16) 68382-186-77 10 BLISTER PACK in 1 CARTON (68382-186-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-186-30)

Ingredients (2)

glipizide (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": "cf07fef0-8b0c-4673-8a46-afbf1d21d0b7", "openfda": {"nui": ["N0000175608", "M0020795"], "upc": ["0368382184016"], "unii": ["X7WDT95N5C", "786Z46389E"], "rxcui": ["861731", "861736", "861740"], "spl_set_id": ["1b18b903-eb52-4d08-b4a5-f984957eb116"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68382-186-01)", "package_ndc": "68382-186-01", "marketing_start_date": "20160505"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (68382-186-10)", "package_ndc": "68382-186-10", "marketing_start_date": "20160505"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68382-186-16)", "package_ndc": "68382-186-16", "marketing_start_date": "20160505"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-186-77)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-186-30)", "package_ndc": "68382-186-77", "marketing_start_date": "20160505"}], "brand_name": "Glipizide and Metformin Hydrochloride", "product_id": "68382-186_cf07fef0-8b0c-4673-8a46-afbf1d21d0b7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "68382-186", "generic_name": "Glipizide and Metformin Hydrochloride", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glipizide and Metformin Hydrochloride", "active_ingredients": [{"name": "GLIPIZIDE", "strength": "5 mg/1"}, {"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA078905", "marketing_category": "ANDA", "marketing_start_date": "20160505", "listing_expiration_date": "20261231"}