glipizide

Generic: glipizide

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glipizide
Generic Name glipizide
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glipizide 5 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-207
Product ID 43353-207_c6784fa1-f4f6-403b-bab4-2e681cf226eb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074223
Listing Expiration 2026-12-31
Marketing Start 1995-02-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43353207
Hyphenated Format 43353-207

Supplemental Identifiers

RxCUI
310490
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 ANDA074223 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 45 TABLET in 1 BOTTLE, PLASTIC (43353-207-45)
  • 90 TABLET in 1 BOTTLE, PLASTIC (43353-207-60)
  • 180 TABLET in 1 BOTTLE, PLASTIC (43353-207-80)
  • 360 TABLET in 1 BOTTLE, PLASTIC (43353-207-94)
source: ndc

Packages (4)

43353-207-45 45 TABLET in 1 BOTTLE, PLASTIC (43353-207-45) 43353-207-60 90 TABLET in 1 BOTTLE, PLASTIC (43353-207-60) 43353-207-80 180 TABLET in 1 BOTTLE, PLASTIC (43353-207-80) 43353-207-94 360 TABLET in 1 BOTTLE, PLASTIC (43353-207-94)

Ingredients (1)

glipizide (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": "c6784fa1-f4f6-403b-bab4-2e681cf226eb", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["X7WDT95N5C"], "rxcui": ["310490"], "spl_set_id": ["d6c016f7-bf93-4322-a179-d4798234b381"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "45 TABLET in 1 BOTTLE, PLASTIC (43353-207-45)", "package_ndc": "43353-207-45", "marketing_start_date": "20160808"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (43353-207-60)", "package_ndc": "43353-207-60", "marketing_start_date": "20160808"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE, PLASTIC (43353-207-80)", "package_ndc": "43353-207-80", "marketing_start_date": "20160808"}, {"sample": false, "description": "360 TABLET in 1 BOTTLE, PLASTIC (43353-207-94)", "package_ndc": "43353-207-94", "marketing_start_date": "20170113"}], "brand_name": "Glipizide", "product_id": "43353-207_c6784fa1-f4f6-403b-bab4-2e681cf226eb", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "43353-207", "generic_name": "Glipizide", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glipizide", "active_ingredients": [{"name": "GLIPIZIDE", "strength": "5 mg/1"}], "application_number": "ANDA074223", "marketing_category": "ANDA", "marketing_start_date": "19950227", "listing_expiration_date": "20261231"}