glimepiride

Generic: glimepiride

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glimepiride
Generic Name glimepiride
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glimepiride 2 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1608
Product ID 67046-1608_48c0ccac-2fbc-0fe2-e063-6294a90a2a9c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202112
Listing Expiration 2027-12-31
Marketing Start 2025-10-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461608
Hyphenated Format 67046-1608

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
  • 30 TABLET in 1 BLISTER PACK (67046-1608-3)
source: ndc

Packages (1)

67046-1608-3 30 TABLET in 1 BLISTER PACK (67046-1608-3)

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": "48c0ccac-2fbc-0fe2-e063-6294a90a2a9c", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["6KY687524K"], "rxcui": ["199246"], "spl_set_id": ["41bf4a72-9288-50a1-e063-6394a90a5e7c"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1608-3)", "package_ndc": "67046-1608-3", "marketing_start_date": "20251022"}], "brand_name": "Glimepiride", "product_id": "67046-1608_48c0ccac-2fbc-0fe2-e063-6294a90a2a9c", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "67046-1608", "generic_name": "Glimepiride", "labeler_name": "Coupler LLC", "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": "20251022", "listing_expiration_date": "20271231"}