imatinib mesylate

Product NDC
16714-705
11-digit product format
167140705
Labeler code
16714
Product ID
16714-705_4a06ae57-2c69-4e11-b7f7-a712dfb04168
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
imatinib mesylate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA078340
Marketing category
ANDA
Marketing start
2017-11-01
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16714-705-012020-08-05C16284748780-1ab0e2407-2950-f274-e053-dbdaa90a6471f27f254e-8d44-4442-84fb-f0745a5342fb
16714-705-012020-07-22C16284748780-1ab0e2407-2950-f274-e053-dbdaa90a6471f27f254e-8d44-4442-84fb-f0745a5342fb

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-705-01EA - Each16714-705070b8917-5cfc-40c8-a007-65997ef08b9d12018-02-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-705-011671407050130 TABLET, FILM COATED in 1 BOTTLE (16714-705-01) 2017-11-010000-00-00NoNoCurrent