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 2 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-065
Product ID 82804-065_0d3fb7c5-9181-4dd7-9724-e26d99d57bbf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202759
Listing Expiration 2027-12-31
Marketing Start 2012-06-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804065
Hyphenated Format 82804-065

Supplemental Identifiers

RxCUI
199246
UPC
0382804065301
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
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (82804-065-30)
  • 60 TABLET in 1 BOTTLE (82804-065-60)
  • 180 TABLET in 1 BOTTLE (82804-065-78)
  • 90 TABLET in 1 BOTTLE (82804-065-90)
source: ndc

Packages (4)

82804-065-30 30 TABLET in 1 BOTTLE (82804-065-30) 82804-065-60 60 TABLET in 1 BOTTLE (82804-065-60) 82804-065-78 180 TABLET in 1 BOTTLE (82804-065-78) 82804-065-90 90 TABLET in 1 BOTTLE (82804-065-90)

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": "0d3fb7c5-9181-4dd7-9724-e26d99d57bbf", "openfda": {"nui": ["N0000175608", "M0020795"], "upc": ["0382804065301"], "unii": ["6KY687524K"], "rxcui": ["199246"], "spl_set_id": ["dbed06f9-7758-4c96-9af0-1ed6103db7df"], "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 (82804-065-30)", "package_ndc": "82804-065-30", "marketing_start_date": "20240131"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (82804-065-60)", "package_ndc": "82804-065-60", "marketing_start_date": "20240131"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (82804-065-78)", "package_ndc": "82804-065-78", "marketing_start_date": "20260218"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (82804-065-90)", "package_ndc": "82804-065-90", "marketing_start_date": "20240131"}], "brand_name": "Glimepiride", "product_id": "82804-065_0d3fb7c5-9181-4dd7-9724-e26d99d57bbf", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "82804-065", "generic_name": "Glimepiride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glimepiride", "active_ingredients": [{"name": "GLIMEPIRIDE", "strength": "2 mg/1"}], "application_number": "ANDA202759", "marketing_category": "ANDA", "marketing_start_date": "20120629", "listing_expiration_date": "20271231"}