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, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

glipizide 2.5 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3645
Product ID 70518-3645_468a709e-0c6f-a258-e063-6394a90a3d69
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203499
Listing Expiration 2026-12-31
Marketing Start 2023-02-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183645
Hyphenated Format 70518-3645

Supplemental Identifiers

RxCUI
310489
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 ANDA203499 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-3645-0)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3645-1)
source: ndc

Packages (2)

70518-3645-0 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-3645-0) 70518-3645-1 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3645-1)

Ingredients (1)

glipizide (2.5 mg/1)

Linked Drug Pages (1)

Glipizide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "468a709e-0c6f-a258-e063-6394a90a3d69", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["X7WDT95N5C"], "rxcui": ["310489"], "spl_set_id": ["e4831ddb-9680-40cb-a060-4ba77c52d0aa"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-3645-0)", "package_ndc": "70518-3645-0", "marketing_start_date": "20230216"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3645-1)", "package_ndc": "70518-3645-1", "marketing_start_date": "20240715"}], "brand_name": "Glipizide", "product_id": "70518-3645_468a709e-0c6f-a258-e063-6394a90a3d69", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "70518-3645", "generic_name": "Glipizide", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glipizide", "active_ingredients": [{"name": "GLIPIZIDE", "strength": "2.5 mg/1"}], "application_number": "ANDA203499", "marketing_category": "ANDA", "marketing_start_date": "20230216", "listing_expiration_date": "20261231"}