glyburide

Generic: glyburide

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

Drug Facts

Product Profile

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

glyburide 2.5 mg/1

Manufacturer
Nivagen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 75834-203
Product ID 75834-203_757b12d9-8efb-49ca-b8f7-7884535ca011
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203379
Listing Expiration 2026-12-31
Marketing Start 2019-01-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75834203
Hyphenated Format 75834-203

Supplemental Identifiers

RxCUI
197737 310534 310537
UPC
0375834202013 0375834204017 0375834203010
UNII
SX6K58TVWC
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 glyburide (source: ndc)
Generic Name glyburide (source: ndc)
Application Number ANDA203379 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (75834-203-00)
  • 100 TABLET in 1 BOTTLE (75834-203-01)
source: ndc

Packages (2)

75834-203-00 1000 TABLET in 1 BOTTLE (75834-203-00) 75834-203-01 100 TABLET in 1 BOTTLE (75834-203-01)

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": "757b12d9-8efb-49ca-b8f7-7884535ca011", "openfda": {"nui": ["N0000175608", "M0020795"], "upc": ["0375834202013", "0375834204017", "0375834203010"], "unii": ["SX6K58TVWC"], "rxcui": ["197737", "310534", "310537"], "spl_set_id": ["43c6f68b-5747-47c6-9538-51ef8c611db4"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Nivagen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (75834-203-00)", "package_ndc": "75834-203-00", "marketing_start_date": "20190125"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (75834-203-01)", "package_ndc": "75834-203-01", "marketing_start_date": "20190125"}], "brand_name": "GLYBURIDE", "product_id": "75834-203_757b12d9-8efb-49ca-b8f7-7884535ca011", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "75834-203", "generic_name": "GLYBURIDE", "labeler_name": "Nivagen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GLYBURIDE", "active_ingredients": [{"name": "GLYBURIDE", "strength": "2.5 mg/1"}], "application_number": "ANDA203379", "marketing_category": "ANDA", "marketing_start_date": "20190125", "listing_expiration_date": "20261231"}