glimepiride

Generic: glimepiride

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

Drug Facts

Product Profile

Brand Name glimepiride
Generic Name glimepiride
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glimepiride 4 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8432
Product ID 68788-8432_5011da39-579e-43ae-b6ef-403c1a75a9a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202759
Listing Expiration 2026-12-31
Marketing Start 2023-04-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888432
Hyphenated Format 68788-8432

Supplemental Identifiers

RxCUI
199247
UNII
6KY687524K
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 glimepiride (source: ndc)
Generic Name glimepiride (source: ndc)
Application Number ANDA202759 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68788-8432-3)
  • 60 TABLET in 1 BOTTLE (68788-8432-6)
  • 90 TABLET in 1 BOTTLE (68788-8432-9)
source: ndc

Packages (3)

68788-8432-3 30 TABLET in 1 BOTTLE (68788-8432-3) 68788-8432-6 60 TABLET in 1 BOTTLE (68788-8432-6) 68788-8432-9 90 TABLET in 1 BOTTLE (68788-8432-9)

Ingredients (1)

glimepiride (4 mg/1)

Linked Drug Pages (1)

Glimepiride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5011da39-579e-43ae-b6ef-403c1a75a9a1", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["6KY687524K"], "rxcui": ["199247"], "spl_set_id": ["744a5cca-7863-491a-b43a-1b649791702c"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8432-3)", "package_ndc": "68788-8432-3", "marketing_start_date": "20230427"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-8432-6)", "package_ndc": "68788-8432-6", "marketing_start_date": "20230427"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8432-9)", "package_ndc": "68788-8432-9", "marketing_start_date": "20230427"}], "brand_name": "Glimepiride", "product_id": "68788-8432_5011da39-579e-43ae-b6ef-403c1a75a9a1", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "68788-8432", "generic_name": "Glimepiride", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glimepiride", "active_ingredients": [{"name": "GLIMEPIRIDE", "strength": "4 mg/1"}], "application_number": "ANDA202759", "marketing_category": "ANDA", "marketing_start_date": "20230427", "listing_expiration_date": "20261231"}