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 2 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8728
Product ID 68788-8728_595c8d9b-dfb7-4914-a53c-3f846c3056f7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202112
Listing Expiration 2026-12-31
Marketing Start 2024-08-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888728
Hyphenated Format 68788-8728

Supplemental Identifiers

RxCUI
199246
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 ANDA202112 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68788-8728-1)
  • 30 TABLET in 1 BOTTLE (68788-8728-3)
  • 60 TABLET in 1 BOTTLE (68788-8728-6)
  • 90 TABLET in 1 BOTTLE (68788-8728-9)
source: ndc

Packages (4)

68788-8728-1 100 TABLET in 1 BOTTLE (68788-8728-1) 68788-8728-3 30 TABLET in 1 BOTTLE (68788-8728-3) 68788-8728-6 60 TABLET in 1 BOTTLE (68788-8728-6) 68788-8728-9 90 TABLET in 1 BOTTLE (68788-8728-9)

Ingredients (1)

glimepiride (2 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": "595c8d9b-dfb7-4914-a53c-3f846c3056f7", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["6KY687524K"], "rxcui": ["199246"], "spl_set_id": ["f69e36b9-4940-4f01-b5ea-59dc66dc1e87"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68788-8728-1)", "package_ndc": "68788-8728-1", "marketing_start_date": "20240819"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8728-3)", "package_ndc": "68788-8728-3", "marketing_start_date": "20240819"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-8728-6)", "package_ndc": "68788-8728-6", "marketing_start_date": "20240819"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8728-9)", "package_ndc": "68788-8728-9", "marketing_start_date": "20240819"}], "brand_name": "Glimepiride", "product_id": "68788-8728_595c8d9b-dfb7-4914-a53c-3f846c3056f7", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "68788-8728", "generic_name": "Glimepiride", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glimepiride", "active_ingredients": [{"name": "GLIMEPIRIDE", "strength": "2 mg/1"}], "application_number": "ANDA202112", "marketing_category": "ANDA", "marketing_start_date": "20240819", "listing_expiration_date": "20261231"}