Home NDC 63539-197-90 Vizimpro
Product NDC 63539-197
Requested package NDC 63539-197-90
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N211288-001 VIZIMPRO DACOMITINIB 15MG TABLET / ORAL RLD 2018-09-27 N211288-002 VIZIMPRO DACOMITINIB 30MG TABLET / ORAL RLD 2018-09-27 N211288-003 VIZIMPRO DACOMITINIB 45MG TABLET / ORAL RLD, RS 2018-09-27
Orange Book patents# Current patent rows page 1 of 1 · 9 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211288-001 10596162 2026-02-02 U-3338 2022-04-13 N211288-001 10603314 2026-02-02 U-3337 2022-04-13 N211288-001 7772243 2032-09-27 Drug substance, Drug product 2018-10-25 N211288-002 10596162 2026-02-02 U-3338 2022-04-13 N211288-002 10603314 2026-02-02 U-3337 2022-04-13 N211288-002 7772243 2032-09-27 Drug substance, Drug product 2018-10-25 N211288-003 10596162 2026-02-02 U-3338 2022-04-13 N211288-003 10603314 2026-02-02 U-3337 2022-04-13 N211288-003 7772243 2032-09-27 Drug substance, Drug product 2018-10-25
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N211288-001 VIZIMPRO 15MG TABLET / ORAL RLD 2018-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211288-002 VIZIMPRO 30MG TABLET / ORAL RLD 2018-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211288-003 VIZIMPRO 45MG TABLET / ORAL RLD, RS 2018-09-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211288-001 VIZIMPRO 15MG TABLET / ORAL RLD 2018-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211288-002 VIZIMPRO 30MG TABLET / ORAL RLD 2018-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211288-003 VIZIMPRO 45MG TABLET / ORAL RLD, RS 2018-09-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211288-001 VIZIMPRO 15MG TABLET / ORAL RLD 2018-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211288-002 VIZIMPRO 30MG TABLET / ORAL RLD 2018-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211288-003 VIZIMPRO 45MG TABLET / ORAL RLD, RS 2018-09-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211288-001 VIZIMPRO 15MG TABLET / ORAL RLD 2018-09-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211288-002 VIZIMPRO 30MG TABLET / ORAL RLD 2018-09-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211288-003 VIZIMPRO 45MG TABLET / ORAL RLD, RS 2018-09-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211288-001 VIZIMPRO 15MG TABLET / ORAL RLD 2018-09-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211288-002 VIZIMPRO 30MG TABLET / ORAL RLD 2018-09-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211288-003 VIZIMPRO 45MG TABLET / ORAL RLD, RS 2018-09-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211288-001 VIZIMPRO 15MG TABLET / ORAL RLD 2018-09-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211288-002 VIZIMPRO 30MG TABLET / ORAL RLD 2018-09-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211288-003 VIZIMPRO 45MG TABLET / ORAL RLD, RS 2018-09-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211288-001 VIZIMPRO 15MG TABLET / ORAL RLD 2018-09-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211288-002 VIZIMPRO 30MG TABLET / ORAL RLD 2018-09-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211288-003 VIZIMPRO 45MG TABLET / ORAL RLD, RS 2018-09-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211288-001 VIZIMPRO 15MG TABLET / ORAL RLD 2018-09-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211288-002 VIZIMPRO 30MG TABLET / ORAL RLD 2018-09-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211288-003 VIZIMPRO 45MG TABLET / ORAL RLD, RS 2018-09-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211288-001 VIZIMPRO 15MG TABLET / ORAL RLD 2018-09-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211288-002 VIZIMPRO 30MG TABLET / ORAL RLD 2018-09-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211288-003 VIZIMPRO 45MG TABLET / ORAL RLD, RS 2018-09-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211288-001 VIZIMPRO 15MG TABLET / ORAL RLD 2018-09-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211288-002 VIZIMPRO 30MG TABLET / ORAL RLD 2018-09-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211288-003 VIZIMPRO 45MG TABLET / ORAL RLD, RS 2018-09-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211288-001 VIZIMPRO 15MG TABLET / ORAL RLD 2018-09-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211288-002 VIZIMPRO 30MG TABLET / ORAL RLD 2018-09-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211288-003 VIZIMPRO 45MG TABLET / ORAL RLD, RS 2018-09-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211288-001 VIZIMPRO 15MG TABLET / ORAL RLD 2018-09-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211288-002 VIZIMPRO 30MG TABLET / ORAL RLD 2018-09-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211288-003 VIZIMPRO 45MG TABLET / ORAL RLD, RS 2018-09-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211288-001 VIZIMPRO 15MG TABLET / ORAL RLD 2018-09-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211288-002 VIZIMPRO 30MG TABLET / ORAL RLD 2018-09-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211288-003 VIZIMPRO 45MG TABLET / ORAL RLD, RS 2018-09-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211288-001 VIZIMPRO 15MG TABLET / ORAL RLD 2018-09-27 8072bd15b7f6…
Observed Orange Book patent history# Patent history page 1 of 11 · 414 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N211288-001 10596162 2026-02-02 U-3338 2022-04-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211288-001 10603314 2026-02-02 U-3337 2022-04-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211288-001 7772243 2032-09-27 Drug substance, Drug product 2018-10-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211288-002 10596162 2026-02-02 U-3338 2022-04-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211288-002 10603314 2026-02-02 U-3337 2022-04-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211288-002 7772243 2032-09-27 Drug substance, Drug product 2018-10-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211288-003 10596162 2026-02-02 U-3338 2022-04-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211288-003 10603314 2026-02-02 U-3337 2022-04-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211288-003 7772243 2032-09-27 Drug substance, Drug product 2018-10-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211288-001 8623883 2025-05-05 U-1403 2018-10-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211288-001 10596162 2026-02-02 U-3338 2022-04-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211288-001 10603314 2026-02-02 U-3337 2022-04-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211288-001 7772243 2028-05-05 Drug substance, Drug product 2018-10-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211288-002 8623883 2025-05-05 U-1403 2018-10-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211288-002 10596162 2026-02-02 U-3338 2022-04-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211288-002 10603314 2026-02-02 U-3337 2022-04-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211288-002 7772243 2028-05-05 Drug substance, Drug product 2018-10-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211288-003 8623883 2025-05-05 U-1403 2018-10-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211288-003 10596162 2026-02-02 U-3338 2022-04-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211288-003 10603314 2026-02-02 U-3337 2022-04-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211288-003 7772243 2028-05-05 Drug substance, Drug product 2018-10-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211288-001 8623883 2025-05-05 U-1403 2018-10-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211288-001 10596162 2026-02-02 U-3338 2022-04-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211288-001 10603314 2026-02-02 U-3337 2022-04-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211288-001 7772243 2028-05-05 Drug substance, Drug product 2018-10-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211288-002 8623883 2025-05-05 U-1403 2018-10-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211288-002 10596162 2026-02-02 U-3338 2022-04-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211288-002 10603314 2026-02-02 U-3337 2022-04-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211288-002 7772243 2028-05-05 Drug substance, Drug product 2018-10-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211288-003 8623883 2025-05-05 U-1403 2018-10-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211288-003 10596162 2026-02-02 U-3338 2022-04-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211288-003 10603314 2026-02-02 U-3337 2022-04-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211288-003 7772243 2028-05-05 Drug substance, Drug product 2018-10-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211288-001 8623883 2025-05-05 U-1403 2018-10-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211288-001 10596162 2026-02-02 U-3338 2022-04-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211288-001 10603314 2026-02-02 U-3337 2022-04-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211288-001 7772243 2028-08-26 Drug substance, Drug product 2018-10-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211288-002 8623883 2025-05-05 U-1403 2018-10-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211288-002 10596162 2026-02-02 U-3338 2022-04-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211288-002 10603314 2026-02-02 U-3337 2022-04-13 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 8 · 306 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211288-001 ODE-206 2025-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211288-001 ODE-213 2025-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211288-002 ODE-206 2025-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211288-002 ODE-213 2025-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211288-003 ODE-206 2025-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211288-003 ODE-213 2025-09-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211288-001 ODE-206 2025-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211288-001 ODE-213 2025-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211288-002 ODE-206 2025-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211288-002 ODE-213 2025-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211288-003 ODE-206 2025-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211288-003 ODE-213 2025-09-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211288-001 ODE-206 2025-09-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211288-001 ODE-213 2025-09-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211288-002 ODE-206 2025-09-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211288-002 ODE-213 2025-09-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211288-003 ODE-206 2025-09-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211288-003 ODE-213 2025-09-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211288-001 ODE-206 2025-09-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211288-001 ODE-213 2025-09-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211288-002 ODE-206 2025-09-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211288-002 ODE-213 2025-09-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211288-003 ODE-206 2025-09-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211288-003 ODE-213 2025-09-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211288-001 ODE-206 2025-09-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211288-001 ODE-213 2025-09-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211288-002 ODE-206 2025-09-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211288-002 ODE-213 2025-09-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211288-003 ODE-206 2025-09-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211288-003 ODE-213 2025-09-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211288-001 ODE-206 2025-09-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211288-001 ODE-213 2025-09-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211288-002 ODE-206 2025-09-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211288-002 ODE-213 2025-09-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211288-003 ODE-206 2025-09-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211288-003 ODE-213 2025-09-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211288-001 ODE-206 2025-09-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211288-001 ODE-213 2025-09-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211288-002 ODE-206 2025-09-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211288-002 ODE-213 2025-09-27 5bbf6a4d5a75…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63539-197-90 Vizimpro 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63539-197 VIZIMPRO (DACOMITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 8 Current NDC, Legacy NDC, 1 package rows 20250112_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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Vizimpro DACOMITINIB Pfizer Laboratories Div Pfizer Inc 4ab27d2f-e385-4e9c-b324-fa69c10b855a 2026-06-23 Warnings, Adverse reactions Exact identifier application applno (NDA): 211288 application number: NDA211288
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63539-197-90 63539019790 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63539-197-90) 2019-02-01 0000-00-00 No No Current