glipizide

Generic: glipizide

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

Drug Facts

Product Profile

Brand Name glipizide
Generic Name glipizide
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

glipizide 5 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-1063
Product ID 70518-1063_484b2c59-7af3-62c2-e063-6294a90ac3ac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204720
Listing Expiration 2027-12-31
Marketing Start 2018-03-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705181063
Hyphenated Format 70518-1063

Supplemental Identifiers

RxCUI
314006
UNII
X7WDT95N5C
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 (source: ndc)
Generic Name glipizide (source: ndc)
Application Number ANDA204720 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-1063-0)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-1063-1)
source: ndc

Packages (2)

Ingredients (1)

glipizide (5 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "484b2c59-7af3-62c2-e063-6294a90ac3ac", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["X7WDT95N5C"], "rxcui": ["314006"], "spl_set_id": ["c2aadc88-22d2-467c-b2cb-03efb5a1f1c1"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-1063-0)", "package_ndc": "70518-1063-0", "marketing_start_date": "20180313"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-1063-1)", "package_ndc": "70518-1063-1", "marketing_start_date": "20180321"}], "brand_name": "Glipizide", "product_id": "70518-1063_484b2c59-7af3-62c2-e063-6294a90ac3ac", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "70518-1063", "generic_name": "Glipizide", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glipizide", "active_ingredients": [{"name": "GLIPIZIDE", "strength": "5 mg/1"}], "application_number": "ANDA204720", "marketing_category": "ANDA", "marketing_start_date": "20180313", "listing_expiration_date": "20271231"}