glyburide

Generic: glyburide

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

Drug Facts

Product Profile

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

glyburide 2.5 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1620
Product ID 67046-1620_4573af53-70f9-b5d7-e063-6294a90af2e0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074388
Listing Expiration 2026-12-31
Marketing Start 2025-12-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461620
Hyphenated Format 67046-1620

Supplemental Identifiers

RxCUI
310534
UNII
SX6K58TVWC
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 glyburide (source: ndc)
Generic Name glyburide (source: ndc)
Application Number ANDA074388 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1620-3)
source: ndc

Packages (1)

67046-1620-3 30 TABLET in 1 BLISTER PACK (67046-1620-3)

Ingredients (1)

glyburide (2.5 mg/1)

Linked Drug Pages (1)

Glyburide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4573af53-70f9-b5d7-e063-6294a90af2e0", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["SX6K58TVWC"], "rxcui": ["310534"], "spl_set_id": ["4573af7f-3c71-e323-e063-6394a90aa9eb"], "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 (67046-1620-3)", "package_ndc": "67046-1620-3", "marketing_start_date": "20251208"}], "brand_name": "Glyburide", "product_id": "67046-1620_4573af53-70f9-b5d7-e063-6294a90af2e0", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "67046-1620", "generic_name": "Glyburide", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glyburide", "active_ingredients": [{"name": "GLYBURIDE", "strength": "2.5 mg/1"}], "application_number": "ANDA074388", "marketing_category": "ANDA", "marketing_start_date": "20251208", "listing_expiration_date": "20261231"}