glimepiride

Generic: glimepiride

Labeler: accord healthcare inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glimepiride
Generic Name glimepiride
Labeler accord healthcare inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glimepiride 2 mg/1

Manufacturer
Accord Healthcare Inc

Identifiers & Regulatory

Product NDC 16729-002
Product ID 16729-002_415deb6c-47dc-ed2a-e063-6394a90a66fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078181
Listing Expiration 2026-12-31
Marketing Start 2007-08-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729002
Hyphenated Format 16729-002

Supplemental Identifiers

RxCUI
199245 199246 199247
UPC
0316729003018 0316729002011
UNII
6KY687524K
NUI
N0000175608 M0020795

Packaging Origin

Original Packager
true

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 ANDA078181 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (16729-002-01)
  • 500 TABLET in 1 BOTTLE (16729-002-16)
source: ndc

Packages (2)

16729-002-01 100 TABLET in 1 BOTTLE (16729-002-01) 16729-002-16 500 TABLET in 1 BOTTLE (16729-002-16)

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": "415deb6c-47dc-ed2a-e063-6394a90a66fa", "openfda": {"nui": ["N0000175608", "M0020795"], "upc": ["0316729003018", "0316729002011"], "unii": ["6KY687524K"], "rxcui": ["199245", "199246", "199247"], "spl_set_id": ["9b74fbac-9e04-4927-9981-1e3dace89c6d"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Accord Healthcare Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (16729-002-01)", "package_ndc": "16729-002-01", "marketing_start_date": "20070823"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (16729-002-16)", "package_ndc": "16729-002-16", "marketing_start_date": "20160824"}], "brand_name": "Glimepiride", "product_id": "16729-002_415deb6c-47dc-ed2a-e063-6394a90a66fa", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "16729-002", "generic_name": "Glimepiride", "labeler_name": "Accord Healthcare Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glimepiride", "active_ingredients": [{"name": "GLIMEPIRIDE", "strength": "2 mg/1"}], "application_number": "ANDA078181", "marketing_category": "ANDA", "marketing_start_date": "20070823", "listing_expiration_date": "20261231"}