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 68071-3452
Product ID 68071-3452_48860991-6561-7756-e063-6394a90a7d01
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203379
Listing Expiration 2027-12-31
Marketing Start 2021-10-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713452
Hyphenated Format 68071-3452

Supplemental Identifiers

RxCUI
310537
UPC
0368071345230
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 ANDA203379 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68071-3452-3)
  • 60 TABLET in 1 BOTTLE (68071-3452-6)
source: ndc

Packages (2)

68071-3452-3 30 TABLET in 1 BOTTLE (68071-3452-3) 68071-3452-6 60 TABLET in 1 BOTTLE (68071-3452-6)

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": "48860991-6561-7756-e063-6394a90a7d01", "openfda": {"nui": ["N0000175608", "M0020795"], "upc": ["0368071345230"], "unii": ["SX6K58TVWC"], "rxcui": ["310537"], "spl_set_id": ["ffd31d06-6011-34e2-e053-6394a90a437f"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68071-3452-3)", "package_ndc": "68071-3452-3", "marketing_start_date": "20230706"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68071-3452-6)", "package_ndc": "68071-3452-6", "marketing_start_date": "20260116"}], "brand_name": "Glyburide", "product_id": "68071-3452_48860991-6561-7756-e063-6394a90a7d01", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "68071-3452", "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": "ANDA203379", "marketing_category": "ANDA", "marketing_start_date": "20211005", "listing_expiration_date": "20271231"}