IMATINIB MESYLATE

Product NDC
63629-2068
11-digit product format
636292068
Labeler code
63629
Product ID
63629-2068_dd41d8b0-59fb-49b8-8001-34a9f5a9144a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IMATINIB MESYLATE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205990
Marketing category
ANDA
Marketing start
2019-02-08
Marketing end
2023-06-30
Substance
IMATINIB MESYLATE
Active strength
400 mg/1
Pharmacologic classes
Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2068-1EA - Each63629-20682a627a67-7833-4648-b9fd-4f12928021fc12021-03-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2068-16362920680130 TABLET, COATED in 1 BOTTLE (63629-2068-1) 2021-02-040000-00-00NoNoCurrent