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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63539-197DDiscontinued by firm2026-08-11
excluded packagepackage63539-19763539-197-90DDiscontinued by firm2026-08-11

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N211288-001VIZIMPRODACOMITINIB15MGTABLET / ORALRLD2018-09-27
N211288-002VIZIMPRODACOMITINIB30MGTABLET / ORALRLD2018-09-27
N211288-003VIZIMPRODACOMITINIB45MGTABLET / ORALRLD, RS2018-09-27

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N211288-001105961622026-02-02U-33382022-04-13
N211288-001106033142026-02-02U-33372022-04-13
N211288-00177722432032-09-27Drug substance, Drug product2018-10-25
N211288-002105961622026-02-02U-33382022-04-13
N211288-002106033142026-02-02U-33372022-04-13
N211288-00277722432032-09-27Drug substance, Drug product2018-10-25
N211288-003105961622026-02-02U-33382022-04-13
N211288-003106033142026-02-02U-33372022-04-13
N211288-00377722432032-09-27Drug substance, Drug product2018-10-25

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N211288-001VIZIMPRO15MGTABLET / ORALRLD2018-09-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211288-002VIZIMPRO30MGTABLET / ORALRLD2018-09-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211288-003VIZIMPRO45MGTABLET / ORALRLD, RS2018-09-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211288-001VIZIMPRO15MGTABLET / ORALRLD2018-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211288-002VIZIMPRO30MGTABLET / ORALRLD2018-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211288-003VIZIMPRO45MGTABLET / ORALRLD, RS2018-09-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N211288-001VIZIMPRO15MGTABLET / ORALRLD2018-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211288-002VIZIMPRO30MGTABLET / ORALRLD2018-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211288-003VIZIMPRO45MGTABLET / ORALRLD, RS2018-09-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211288-001VIZIMPRO15MGTABLET / ORALRLD2018-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211288-002VIZIMPRO30MGTABLET / ORALRLD2018-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211288-003VIZIMPRO45MGTABLET / ORALRLD, RS2018-09-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211288-001VIZIMPRO15MGTABLET / ORALRLD2018-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211288-002VIZIMPRO30MGTABLET / ORALRLD2018-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211288-003VIZIMPRO45MGTABLET / ORALRLD, RS2018-09-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211288-001VIZIMPRO15MGTABLET / ORALRLD2018-09-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211288-002VIZIMPRO30MGTABLET / ORALRLD2018-09-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211288-003VIZIMPRO45MGTABLET / ORALRLD, RS2018-09-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211288-001VIZIMPRO15MGTABLET / ORALRLD2018-09-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211288-002VIZIMPRO30MGTABLET / ORALRLD2018-09-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211288-003VIZIMPRO45MGTABLET / ORALRLD, RS2018-09-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211288-001VIZIMPRO15MGTABLET / ORALRLD2018-09-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211288-002VIZIMPRO30MGTABLET / ORALRLD2018-09-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211288-003VIZIMPRO45MGTABLET / ORALRLD, RS2018-09-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211288-001VIZIMPRO15MGTABLET / ORALRLD2018-09-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211288-002VIZIMPRO30MGTABLET / ORALRLD2018-09-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211288-003VIZIMPRO45MGTABLET / ORALRLD, RS2018-09-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N211288-001VIZIMPRO15MGTABLET / ORALRLD2018-09-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N211288-002VIZIMPRO30MGTABLET / ORALRLD2018-09-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N211288-003VIZIMPRO45MGTABLET / ORALRLD, RS2018-09-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211288-001VIZIMPRO15MGTABLET / ORALRLD2018-09-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211288-002VIZIMPRO30MGTABLET / ORALRLD2018-09-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211288-003VIZIMPRO45MGTABLET / ORALRLD, RS2018-09-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211288-001VIZIMPRO15MGTABLET / ORALRLD2018-09-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211288-002VIZIMPRO30MGTABLET / ORALRLD2018-09-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211288-003VIZIMPRO45MGTABLET / ORALRLD, RS2018-09-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211288-001VIZIMPRO15MGTABLET / ORALRLD2018-09-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211288-002VIZIMPRO30MGTABLET / ORALRLD2018-09-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211288-003VIZIMPRO45MGTABLET / ORALRLD, RS2018-09-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N211288-001VIZIMPRO15MGTABLET / ORALRLD2018-09-278072bd15b7f6…

Observed Orange Book patent history#

Patent history page 1 of 11 · 414 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N211288-001105961622026-02-02U-33382022-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211288-001106033142026-02-02U-33372022-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211288-00177722432032-09-27Drug substance, Drug product2018-10-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211288-002105961622026-02-02U-33382022-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211288-002106033142026-02-02U-33372022-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211288-00277722432032-09-27Drug substance, Drug product2018-10-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211288-003105961622026-02-02U-33382022-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211288-003106033142026-02-02U-33372022-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211288-00377722432032-09-27Drug substance, Drug product2018-10-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211288-00186238832025-05-05U-14032018-10-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211288-001105961622026-02-02U-33382022-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211288-001106033142026-02-02U-33372022-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211288-00177722432028-05-05Drug substance, Drug product2018-10-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211288-00286238832025-05-05U-14032018-10-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211288-002105961622026-02-02U-33382022-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211288-002106033142026-02-02U-33372022-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211288-00277722432028-05-05Drug substance, Drug product2018-10-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211288-00386238832025-05-05U-14032018-10-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211288-003105961622026-02-02U-33382022-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211288-003106033142026-02-02U-33372022-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211288-00377722432028-05-05Drug substance, Drug product2018-10-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N211288-00186238832025-05-05U-14032018-10-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211288-001105961622026-02-02U-33382022-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211288-001106033142026-02-02U-33372022-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211288-00177722432028-05-05Drug substance, Drug product2018-10-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211288-00286238832025-05-05U-14032018-10-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211288-002105961622026-02-02U-33382022-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211288-002106033142026-02-02U-33372022-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211288-00277722432028-05-05Drug substance, Drug product2018-10-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211288-00386238832025-05-05U-14032018-10-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211288-003105961622026-02-02U-33382022-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211288-003106033142026-02-02U-33372022-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211288-00377722432028-05-05Drug substance, Drug product2018-10-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211288-00186238832025-05-05U-14032018-10-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211288-001105961622026-02-02U-33382022-04-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211288-001106033142026-02-02U-33372022-04-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211288-00177722432028-08-26Drug substance, Drug product2018-10-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211288-00286238832025-05-05U-14032018-10-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211288-002105961622026-02-02U-33382022-04-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211288-002106033142026-02-02U-33372022-04-13fd3edfee7708…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 8 · 306 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211288-001ODE-2062025-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211288-001ODE-2132025-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211288-002ODE-2062025-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211288-002ODE-2132025-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211288-003ODE-2062025-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211288-003ODE-2132025-09-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N211288-001ODE-2062025-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211288-001ODE-2132025-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211288-002ODE-2062025-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211288-002ODE-2132025-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211288-003ODE-2062025-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211288-003ODE-2132025-09-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211288-001ODE-2062025-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211288-001ODE-2132025-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211288-002ODE-2062025-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211288-002ODE-2132025-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211288-003ODE-2062025-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211288-003ODE-2132025-09-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211288-001ODE-2062025-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211288-001ODE-2132025-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211288-002ODE-2062025-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211288-002ODE-2132025-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211288-003ODE-2062025-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211288-003ODE-2132025-09-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211288-001ODE-2062025-09-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211288-001ODE-2132025-09-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211288-002ODE-2062025-09-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211288-002ODE-2132025-09-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211288-003ODE-2062025-09-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211288-003ODE-2132025-09-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211288-001ODE-2062025-09-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211288-001ODE-2132025-09-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211288-002ODE-2062025-09-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211288-002ODE-2132025-09-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211288-003ODE-2062025-09-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211288-003ODE-2132025-09-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211288-001ODE-2062025-09-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211288-001ODE-2132025-09-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211288-002ODE-2062025-09-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211288-002ODE-2132025-09-275bbf6a4d5a75…

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#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VizimproDACOMITINIBPfizer Laboratories Div Pfizer Inc4ab27d2f-e385-4e9c-b324-fa69c10b855a2026-06-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 211288
application number: NDA211288

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