glyBURIDE

Product NDC
52817-121
11-digit product format
528170121
Labeler code
52817
Product ID
52817-121_b7928c2d-1e2e-a219-e053-2995a90aedee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glyBURIDE
Dosage form
TABLET
Route
ORAL
Labeler
TruPharma, LLC
Application
ANDA203581
Marketing category
ANDA
Marketing start
2016-06-01
Marketing end
0000-00-00
Substance
GLYBURIDE
Active strength
3 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-121-10EA - Each52817-121970000ea-8ed0-4824-bb2a-a1109d3d70da12016-09-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52817-121-1052817012110100 TABLET in 1 BOTTLE (52817-121-10) 100 tablet2016-06-010000-00-00NoNoCurrent