Vizimpro

Product NDC: 0069-2299
11-digit product format: 000692299
Labeler code: 0069
Product ID: 0069-2299_cf672c83-c9d9-4107-bcf1-76d4106537cc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dacomitinib
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Pfizer Laboratories Div Pfizer Inc
Application: NDA211288
Marketing category: NDA
Marketing start: 2018-10-04
Marketing end: 2028-10-31
Substance: DACOMITINIB
Active strength: 45 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

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

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	0069-2299		U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0069-2299	0069-2299-30	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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	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	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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Vizimpro

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DACOMITINIB	45 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5092U85G58	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2058915	Internal RxNorm lookup
2058922	Internal RxNorm lookup
2058924	Internal RxNorm lookup
2058926	Internal RxNorm lookup
2058930	Internal RxNorm lookup
2058932	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4ab27d2f-e385-4e9c-b324-fa69c10b855a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
402efe05-5265-440f-a90d-a6535e2dc737	Product name	1	20190103
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0069-2299-30	Vizimpro	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0069-2299-30	EA - Each	0069-2299	3043e6c5-fe71-4e98-b785-9193fc36e7e5	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0069-2299	VIZIMPRO (DACOMITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]	6	Current NDC, Legacy NDC, 1 package rows	20250119_4ab27d2f-e385-4e9c-b324-fa69c10b855a.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 ndc (product): 0069-2299

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5092U85G58	DACOMITINIB	1042385-75-0	DACOMITINIB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2058915	dacomitinib 15 MG Oral Tablet	PSN	4ab27d2f-e385-4e9c-b324-fa69c10b855a	8
2058924	dacomitinib 30 MG Oral Tablet	PSN	4ab27d2f-e385-4e9c-b324-fa69c10b855a	8
2058930	dacomitinib 45 MG Oral Tablet	PSN	4ab27d2f-e385-4e9c-b324-fa69c10b855a	8
2058922	Vizimpro 15 MG Oral Tablet	PSN	4ab27d2f-e385-4e9c-b324-fa69c10b855a	8
2058926	Vizimpro 30 MG Oral Tablet	PSN	4ab27d2f-e385-4e9c-b324-fa69c10b855a	8
2058932	Vizimpro 45 MG Oral Tablet	PSN	4ab27d2f-e385-4e9c-b324-fa69c10b855a	8
2058922	dacomitinib 15 MG Oral Tablet [Vizimpro]	SBD	4ab27d2f-e385-4e9c-b324-fa69c10b855a	8
2058926	dacomitinib 30 MG Oral Tablet [Vizimpro]	SBD	4ab27d2f-e385-4e9c-b324-fa69c10b855a	8
2058932	dacomitinib 45 MG Oral Tablet [Vizimpro]	SBD	4ab27d2f-e385-4e9c-b324-fa69c10b855a	8
2058915	dacomitinib 15 MG Oral Tablet	SCD	4ab27d2f-e385-4e9c-b324-fa69c10b855a	8
2058924	dacomitinib 30 MG Oral Tablet	SCD	4ab27d2f-e385-4e9c-b324-fa69c10b855a	8
2058930	dacomitinib 45 MG Oral Tablet	SCD	4ab27d2f-e385-4e9c-b324-fa69c10b855a	8
2058922	Vizimpro 15 MG Oral Tablet	SY	4ab27d2f-e385-4e9c-b324-fa69c10b855a	8
2058926	Vizimpro 30 MG Oral Tablet	SY	4ab27d2f-e385-4e9c-b324-fa69c10b855a	8
2058932	Vizimpro 45 MG Oral Tablet	SY	4ab27d2f-e385-4e9c-b324-fa69c10b855a	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0069-2299-30	00069229930	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0069-2299-30)	2018-10-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vizimpro	Pfizer Laboratories Div Pfizer Inc \| Pharmacia & Upjohn Company LLC \| Pfizer Ireland Pharmaceuticals Unlimited Company \| Pfizer Manufacturing Deutschland GmbH	2026-06-23	HUMAN PRESCRIPTION DRUG LABEL	9