IMATINIB MESYLATE

Product NDC
68180-390
11-digit product format
681800390
Labeler code
68180
Product ID
68180-390_9a08336f-337e-4024-b775-f9fd858e5168
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IMATINIB
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA207818
Marketing category
ANDA
Marketing start
2019-07-08
Marketing end
0000-00-00
Substance
IMATINIB MESYLATE
Active strength
100 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
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
68180-390-09EA - Each68180-3902b71497f-8282-475f-82a6-0e57c950b2b312019-07-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-390-096818003900990 TABLET, FILM COATED in 1 BOTTLE (68180-390-09) 2019-07-080000-00-00NoNoCurrent