glyburide

Generic: glyburide

Labeler: nucare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glyburide
Generic Name glyburide
Labeler nucare pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glyburide 5 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3677
Product ID 68071-3677_217890d0-dc57-e148-e063-6294a90a9b0a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074388
Listing Expiration 2026-12-31
Marketing Start 1995-08-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713677
Hyphenated Format 68071-3677

Supplemental Identifiers

RxCUI
310537
UPC
0368071367706
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
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68071-3677-0)
source: ndc

Packages (1)

68071-3677-0 100 TABLET in 1 BOTTLE (68071-3677-0)

Ingredients (1)

glyburide (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": "217890d0-dc57-e148-e063-6294a90a9b0a", "openfda": {"nui": ["N0000175608", "M0020795"], "upc": ["0368071367706"], "unii": ["SX6K58TVWC"], "rxcui": ["310537"], "spl_set_id": ["21786ac0-da3c-16cb-e063-6394a90a4596"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68071-3677-0)", "package_ndc": "68071-3677-0", "marketing_start_date": "20240906"}], "brand_name": "Glyburide", "product_id": "68071-3677_217890d0-dc57-e148-e063-6294a90a9b0a", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "68071-3677", "generic_name": "Glyburide", "labeler_name": "NuCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glyburide", "active_ingredients": [{"name": "GLYBURIDE", "strength": "5 mg/1"}], "application_number": "ANDA074388", "marketing_category": "ANDA", "marketing_start_date": "19950830", "listing_expiration_date": "20261231"}