glimepiride

Generic: glimepiride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glimepiride
Generic Name glimepiride
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glimepiride 1 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-140
Product ID 82804-140_1f102e4c-1954-4f17-8c60-4dad79f25a25
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077091
Listing Expiration 2026-12-31
Marketing Start 2005-10-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804140
Hyphenated Format 82804-140

Supplemental Identifiers

RxCUI
199245
UPC
0382804140305
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 ANDA077091 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (82804-140-30)
  • 90 TABLET in 1 BOTTLE (82804-140-90)
source: ndc

Packages (2)

82804-140-30 30 TABLET in 1 BOTTLE (82804-140-30) 82804-140-90 90 TABLET in 1 BOTTLE (82804-140-90)

Ingredients (1)

glimepiride (1 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": "1f102e4c-1954-4f17-8c60-4dad79f25a25", "openfda": {"nui": ["N0000175608", "M0020795"], "upc": ["0382804140305"], "unii": ["6KY687524K"], "rxcui": ["199245"], "spl_set_id": ["1f102e4c-1954-4f17-8c60-4dad79f25a25"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (82804-140-30)", "package_ndc": "82804-140-30", "marketing_start_date": "20240911"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (82804-140-90)", "package_ndc": "82804-140-90", "marketing_start_date": "20240911"}], "brand_name": "Glimepiride", "product_id": "82804-140_1f102e4c-1954-4f17-8c60-4dad79f25a25", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "82804-140", "generic_name": "Glimepiride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glimepiride", "active_ingredients": [{"name": "GLIMEPIRIDE", "strength": "1 mg/1"}], "application_number": "ANDA077091", "marketing_category": "ANDA", "marketing_start_date": "20051006", "listing_expiration_date": "20261231"}