glipizide and metformin hydrochloride

Generic: glipizide and metformin hydrochloride

Labeler: remedyrepack 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 remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-0908
Product ID 70518-0908_4aa47708-3e69-f5cc-e063-6394a90a0eb1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078905
Listing Expiration 2027-12-31
Marketing Start 2017-12-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705180908
Hyphenated Format 70518-0908

Supplemental Identifiers

RxCUI
861740
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 ANDA078905 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 500 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0908-1)
source: ndc

Packages (1)

70518-0908-1 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0908-1)

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": "4aa47708-3e69-f5cc-e063-6394a90a0eb1", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["X7WDT95N5C", "786Z46389E"], "rxcui": ["861740"], "spl_set_id": ["b7a27f1e-6290-4649-8a93-2a48ba105618"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0908-1)", "package_ndc": "70518-0908-1", "marketing_start_date": "20171227"}], "brand_name": "Glipizide and Metformin Hydrochloride", "product_id": "70518-0908_4aa47708-3e69-f5cc-e063-6394a90a0eb1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "70518-0908", "generic_name": "Glipizide and Metformin Hydrochloride", "labeler_name": "REMEDYREPACK 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": "20171213", "listing_expiration_date": "20271231"}