Glyburide

Product NDC
68071-3677
11-digit product format
680713677
Labeler code
68071
Product ID
68071-3677_217890d0-dc57-e148-e063-6294a90a9b0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA074388
Marketing category
ANDA
Marketing start
1995-08-30
Substance
GLYBURIDE
Active strength
5 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
SX6K58TVWCGLYBURIDE10238-21-8GLYBURIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3677-068071367700100 TABLET in 1 BOTTLE (68071-3677-0) 100 tablet2024-09-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
GLYBURIDE TABLETS USP 1.25, 2.5, and 5 mg 8342 8343 8344 Rx onlyNuCare Pharmaceuticals, Inc.2024-09-06HUMAN PRESCRIPTION DRUG LABEL1