FDA.reportPublic FDA data

Vizimpro

Product NDC
63539-197
11-digit product format
635390197
Labeler code
63539
Product ID
63539-197_b0b607d1-7a3d-40a2-bf2e-b7eb0f00f762
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dacomitinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
U.S. Pharmaceuticals
Application
NDA211288
Marketing category
NDA
Marketing start
2019-02-01
Substance
DACOMITINIB
Active strength
15 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
402efe05-5265-440f-a90d-a6535e2dc737Product name120190103
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63539-197-902021-08-14C16284748780-1ab0e2407-28b4-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use VIZIMPRO safely and effectively. See full prescribing information for VIZIMPRO. VIZIMPRO ® (dacomitinib) tablets, for oral use Initial U.S. Approval: 2018
63539-197-902021-07-23C16284748780-1ab0e2407-28b4-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use VIZIMPRO safely and effectively. See full prescribing information for VIZIMPRO. VIZIMPRO ® (dacomitinib) tablets, for oral use Initial U.S. Approval: 2018
63539-197-902020-08-20C16284748780-1ab0e2407-28b4-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use VIZIMPRO safely and effectively. See full prescribing information for VIZIMPRO. VIZIMPRO ® (dacomitinib) tablets, for oral use Initial U.S. Approval: 2018
63539-197-902020-07-22C16284748780-1ab0e2407-28b4-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use VIZIMPRO safely and effectively. See full prescribing information for VIZIMPRO. VIZIMPRO ® (dacomitinib) tablets, for oral use Initial U.S. Approval: 2018

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63539-197-90Vizimpro90 in 1 BOTTLE, PLASTICTABLET, FILM COATED909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63539-197VIZIMPRO (DACOMITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS]8Current NDC, Legacy NDC, 1 package rows20250112_90da33c1-5689-4b4d-a2b5-377e1057a843.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63539-197-906353901979090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63539-197-90) 2019-02-010000-00-00NoNoCurrent