PEMAZYRE

Product NDC: 50881-027
11-digit product format: 508810027
Labeler code: 50881
Product ID: 50881-027_741de3ad-f255-4da5-b43a-60a99caf4137
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pemigatinib
Dosage form: TABLET
Route: ORAL
Labeler: Incyte Corporation
Application: NDA213736
Marketing category: NDA
Marketing start: 2020-04-17
Substance: PEMIGATINIB
Active strength: 9 mg/1
Pharmacologic classes: Kinase Inhibitor [EPC], Kinase Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N213736-001	PEMAZYRE	PEMIGATINIB	4.5MG	TABLET / ORAL	RLD	2020-04-17
N213736-002	PEMAZYRE	PEMIGATINIB	9MG	TABLET / ORAL	RLD	2020-04-17
N213736-003	PEMAZYRE	PEMIGATINIB	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17

Orange Book patents#

Current patent rows page 1 of 1 · 30 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213736-001	10131667	2034-04-17	U-2809		2020-05-14
N213736-001	9611267	2035-01-30		Drug substance, Drug product	2020-05-14
N213736-001	11466004	2039-05-03	U-3464		2022-11-07
N213736-001	11466004	2039-05-03	U-3465		2022-11-07
N213736-001	11466004	2039-05-03	U-3466		2022-11-07
N213736-001	11628162	2040-08-30	U-3568		2023-05-15
N213736-001	11628162	2040-08-30	U-3569		2023-05-15
N213736-001	11628162	2040-08-30	U-3570		2023-05-15
N213736-001	11628162	2040-08-30	U-3571		2023-05-15
N213736-001	12552792	2040-10-03		Drug substance, Drug product	2026-03-18
N213736-002	10131667	2034-04-17	U-2809		2020-05-14
N213736-002	9611267	2035-01-30		Drug substance, Drug product	2020-05-14
N213736-002	11466004	2039-05-03	U-3464		2022-11-07
N213736-002	11466004	2039-05-03	U-3465		2022-11-07
N213736-002	11466004	2039-05-03	U-3466		2022-11-07
N213736-002	11628162	2040-08-30	U-3568		2023-05-15
N213736-002	11628162	2040-08-30	U-3569		2023-05-15
N213736-002	11628162	2040-08-30	U-3570		2023-05-15
N213736-002	11628162	2040-08-30	U-3571		2023-05-15
N213736-002	12552792	2040-10-03		Drug substance, Drug product	2026-03-18
N213736-003	10131667	2034-04-17	U-2809		2020-05-14
N213736-003	9611267	2035-01-30		Drug substance, Drug product	2020-05-14
N213736-003	11466004	2039-05-03	U-3464		2022-11-07
N213736-003	11466004	2039-05-03	U-3465		2022-11-07
N213736-003	11466004	2039-05-03	U-3466		2022-11-07
N213736-003	11628162	2040-08-30	U-3568		2023-05-15
N213736-003	11628162	2040-08-30	U-3569		2023-05-15
N213736-003	11628162	2040-08-30	U-3570		2023-05-15
N213736-003	11628162	2040-08-30	U-3571		2023-05-15
N213736-003	12552792	2040-10-03		Drug substance, Drug product	2026-03-18

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213736-001	ODE-292	2027-04-17
N213736-001	ODE-404	2029-08-26
N213736-002	ODE-292	2027-04-17
N213736-002	ODE-404	2029-08-26
N213736-003	ODE-292	2027-04-17
N213736-003	ODE-404	2029-08-26

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 3 · 117 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 20 · 774 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N213736-001	10131667	2034-04-17	U-2809		2020-05-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-001	9611267	2035-01-30		Drug substance, Drug product	2020-05-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-001	11466004	2039-05-03	U-3464		2022-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-001	11466004	2039-05-03	U-3465		2022-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-001	11466004	2039-05-03	U-3466		2022-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-001	11628162	2040-08-30	U-3568		2023-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-001	11628162	2040-08-30	U-3569		2023-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-001	11628162	2040-08-30	U-3570		2023-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-001	11628162	2040-08-30	U-3571		2023-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-001	12552792	2040-10-03		Drug substance, Drug product	2026-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	10131667	2034-04-17	U-2809		2020-05-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	9611267	2035-01-30		Drug substance, Drug product	2020-05-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	11466004	2039-05-03	U-3464		2022-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	11466004	2039-05-03	U-3465		2022-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	11466004	2039-05-03	U-3466		2022-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	11628162	2040-08-30	U-3568		2023-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	11628162	2040-08-30	U-3569		2023-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	11628162	2040-08-30	U-3570		2023-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	11628162	2040-08-30	U-3571		2023-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	12552792	2040-10-03		Drug substance, Drug product	2026-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	10131667	2034-04-17	U-2809		2020-05-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	9611267	2035-01-30		Drug substance, Drug product	2020-05-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	11466004	2039-05-03	U-3464		2022-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	11466004	2039-05-03	U-3465		2022-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	11466004	2039-05-03	U-3466		2022-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	11628162	2040-08-30	U-3569		2023-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	11628162	2040-08-30	U-3568		2023-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	11628162	2040-08-30	U-3570		2023-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	11628162	2040-08-30	U-3571		2023-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	12552792	2040-10-03		Drug substance, Drug product	2026-03-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213736-001	10131667	2034-04-17	U-2809		2020-05-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-001	9611267	2035-01-30		Drug substance, Drug product	2020-05-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-001	11466004	2039-05-03	U-3464		2022-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-001	11466004	2039-05-03	U-3465		2022-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-001	11466004	2039-05-03	U-3466		2022-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-001	11628162	2040-08-30	U-3568		2023-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-001	11628162	2040-08-30	U-3569		2023-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-001	11628162	2040-08-30	U-3570		2023-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-001	11628162	2040-08-30	U-3571		2023-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-001	12552792	2040-10-03		Drug substance, Drug product	2026-03-18	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 10 · 369 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N213736-001	ODE-292	2027-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-001	ODE-404	2029-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	ODE-292	2027-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	ODE-404	2029-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	ODE-292	2027-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	ODE-404	2029-08-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213736-001	ODE-292	2027-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-001	ODE-404	2029-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-002	ODE-292	2027-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-002	ODE-404	2029-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-003	ODE-292	2027-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-003	ODE-404	2029-08-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213736-001	ODE-292	2027-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213736-001	ODE-404	2029-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213736-002	ODE-292	2027-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213736-002	ODE-404	2029-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213736-003	ODE-292	2027-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213736-003	ODE-404	2029-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-001	NCE	2025-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-001	I-899	2025-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-001	ODE-292	2027-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-001	ODE-404	2029-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-002	NCE	2025-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-002	I-899	2025-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-002	ODE-292	2027-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-002	ODE-404	2029-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-003	NCE	2025-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-003	I-899	2025-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-003	ODE-292	2027-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-003	ODE-404	2029-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213736-001	NCE	2025-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213736-001	I-899	2025-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213736-001	ODE-292	2027-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213736-001	ODE-404	2029-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213736-002	NCE	2025-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213736-002	I-899	2025-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213736-002	ODE-292	2027-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213736-002	ODE-404	2029-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213736-003	NCE	2025-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213736-003	I-899	2025-08-26	`6a471c1ec25d…`

Additional Listing Data#

Finished product: Yes
Brand name base: PEMAZYRE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PEMIGATINIB	9 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Y6BX7BL23K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2359334	Internal RxNorm lookup
2359340	Internal RxNorm lookup
2359342	Internal RxNorm lookup
2359344	Internal RxNorm lookup
2359346	Internal RxNorm lookup
2359348	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
9e1f2222-1d89-4e63-989c-ccebe2ab1eb4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d0ef7b74-0af1-46d3-92f3-fa502ba149f5	Product name	1	20200728

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50881-027-01	PEMAZYRE	14 in 1 BOTTLE, PLASTIC	TABLET	14		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50881-027-01	EA - Each	50881-027	cfd469ff-a8fb-4a17-9668-731dec05a1f5	1	2020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50881-027	PEMAZYRE (PEMIGATINIB) TABLET [INCYTE CORPORATION]	11	Current NDC, Legacy NDC, 1 package rows	20230615_9e1f2222-1d89-4e63-989c-ccebe2ab1eb4.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
PEMAZYRE	PEMIGATINIB	Incyte Corporation	9e1f2222-1d89-4e63-989c-ccebe2ab1eb4	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213736 application number: NDA213736 ndc (product): 50881-027

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Y6BX7BL23K	PEMIGATINIB	1513857-77-6	PEMIGATINIB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2359340	Pemazyre 13.5 MG Oral Tablet	PSN	9e1f2222-1d89-4e63-989c-ccebe2ab1eb4	15
2359344	Pemazyre 4.5 MG Oral Tablet	PSN	9e1f2222-1d89-4e63-989c-ccebe2ab1eb4	15
2359348	Pemazyre 9 MG Oral Tablet	PSN	9e1f2222-1d89-4e63-989c-ccebe2ab1eb4	15
2359334	pemigatinib 13.5 MG Oral Tablet	PSN	9e1f2222-1d89-4e63-989c-ccebe2ab1eb4	15
2359342	pemigatinib 4.5 MG Oral Tablet	PSN	9e1f2222-1d89-4e63-989c-ccebe2ab1eb4	15
2359346	pemigatinib 9 MG Oral Tablet	PSN	9e1f2222-1d89-4e63-989c-ccebe2ab1eb4	15
2359340	pemigatinib 13.5 MG Oral Tablet [Pemazyre]	SBD	9e1f2222-1d89-4e63-989c-ccebe2ab1eb4	15
2359344	pemigatinib 4.5 MG Oral Tablet [Pemazyre]	SBD	9e1f2222-1d89-4e63-989c-ccebe2ab1eb4	15
2359348	pemigatinib 9 MG Oral Tablet [Pemazyre]	SBD	9e1f2222-1d89-4e63-989c-ccebe2ab1eb4	15
2359334	pemigatinib 13.5 MG Oral Tablet	SCD	9e1f2222-1d89-4e63-989c-ccebe2ab1eb4	15
2359342	pemigatinib 4.5 MG Oral Tablet	SCD	9e1f2222-1d89-4e63-989c-ccebe2ab1eb4	15
2359346	pemigatinib 9 MG Oral Tablet	SCD	9e1f2222-1d89-4e63-989c-ccebe2ab1eb4	15
2359340	Pemazyre 13.5 MG Oral Tablet	SY	9e1f2222-1d89-4e63-989c-ccebe2ab1eb4	15
2359344	Pemazyre 4.5 MG Oral Tablet	SY	9e1f2222-1d89-4e63-989c-ccebe2ab1eb4	15
2359348	Pemazyre 9 MG Oral Tablet	SY	9e1f2222-1d89-4e63-989c-ccebe2ab1eb4	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50881-027-01	50881002701	14 TABLET in 1 BOTTLE, PLASTIC (50881-027-01)	14 tablet	2020-04-17	0000-00-00	No	No	Current