glipizide and metformin hcl

Generic: glipizide and metformin hcl

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glipizide and metformin hcl
Generic Name glipizide and metformin hcl
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 70518-1594
Product ID 70518-1594_494e32b2-c5d4-db3f-e063-6394a90aaa0d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078728
Listing Expiration 2027-12-31
Marketing Start 2018-10-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705181594
Hyphenated Format 70518-1594

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 hcl (source: ndc)
Generic Name glipizide and metformin hcl (source: ndc)
Application Number ANDA078728 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 500 mg/1
source: ndc
Packaging
  • 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1594-0)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1594-1)
source: ndc

Packages (2)

70518-1594-0 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1594-0) 70518-1594-1 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1594-1)

Ingredients (2)

glipizide (5 mg/1) metformin hydrochloride (500 mg/1)

Linked Drug Pages (1)

Glipizide and Metformin HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "494e32b2-c5d4-db3f-e063-6394a90aaa0d", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["X7WDT95N5C", "786Z46389E"], "rxcui": ["861740"], "spl_set_id": ["b64517f9-f3b7-4254-9713-e68a4d98da90"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1594-0)", "package_ndc": "70518-1594-0", "marketing_start_date": "20181026"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1594-1)", "package_ndc": "70518-1594-1", "marketing_start_date": "20190114"}], "brand_name": "Glipizide and Metformin HCl", "product_id": "70518-1594_494e32b2-c5d4-db3f-e063-6394a90aaa0d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "70518-1594", "generic_name": "Glipizide and Metformin HCl", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glipizide and Metformin HCl", "active_ingredients": [{"name": "GLIPIZIDE", "strength": "5 mg/1"}, {"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA078728", "marketing_category": "ANDA", "marketing_start_date": "20181026", "listing_expiration_date": "20271231"}