EXKIVITY

Product NDC: 63020-040
Requested package NDC: 63020-040-12
11-digit product format: 630200040
Labeler code: 63020
Product ID: 63020-040_46bccc44-788b-444f-a47d-8b6e8f81d30b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mobocertinib
Dosage form: CAPSULE
Route: ORAL
Labeler: Takeda Pharmaceuticals America, Inc.
Application: NDA215310
Marketing category: NDA
Marketing start: 2021-09-15
Marketing end: 0000-00-00
Substance: MOBOCERTINIB
Active strength: 40 mg/1
Pharmacologic classes: Cytochrome P450 3A Inducers [MoA], HER1 Antagonists [MoA], Kinase Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63020-040	63020-040-12	D	Discontinued by firm		2026-10-05

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 · 5 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N215310-001	EXKIVITY	MOBOCERTINIB SUCCINATE	EQ 40MG BASE	CAPSULE / ORAL		RLD	2021-09-15

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215310-001	10227342	2035-05-13	U-3220	Drug substance, Drug product	2021-10-05
N215310-001	9796712	2035-05-13		Drug substance, Drug product	2021-10-05

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215310-001	NCE	2026-09-15
N215310-001	ODE-374	2028-09-15

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.

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	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD	2021-09-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD	2021-09-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD	2021-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD	2021-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD	2021-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD	2021-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD	2021-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD	2021-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD	2021-09-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD	2021-09-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD	2021-09-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD	2021-09-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD	2021-09-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD	2021-09-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD	2021-09-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD	2021-09-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD, RS	2021-09-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD, RS	2021-09-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD, RS	2021-09-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD, RS	2021-09-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD, RS	2021-09-15	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD, RS	2021-09-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD, RS	2021-09-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD, RS	2021-09-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD, RS	2021-09-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD, RS	2021-09-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD, RS	2021-09-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD, RS	2021-09-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD, RS	2021-09-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD, RS	2021-09-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD, RS	2021-09-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD, RS	2021-09-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD, RS	2021-09-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD, RS	2021-09-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215310-001	EXKIVITY	EQ 40MG BASE	CAPSULE / ORAL	RLD	2021-09-15	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 70 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	N215310-001	10227342	2035-05-13	U-3220	Drug substance, Drug product	2021-10-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215310-001	9796712	2035-05-13		Drug substance, Drug product	2021-10-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215310-001	10227342	2035-05-13	U-3220	Drug substance, Drug product	2021-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215310-001	9796712	2035-05-13		Drug substance, Drug product	2021-10-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215310-001	10227342	2035-05-13	U-3220	Drug substance, Drug product	2021-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215310-001	9796712	2035-05-13		Drug substance, Drug product	2021-10-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215310-001	10227342	2035-05-13	U-3220	Drug substance, Drug product	2021-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215310-001	9796712	2035-05-13		Drug substance, Drug product	2021-10-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215310-001	10227342	2035-05-13	U-3220	Drug substance, Drug product	2021-10-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215310-001	9796712	2035-05-13		Drug substance, Drug product	2021-10-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215310-001	10227342	2035-05-13	U-3220	Drug substance, Drug product	2021-10-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215310-001	9796712	2035-05-13		Drug substance, Drug product	2021-10-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215310-001	10227342	2035-05-13	U-3220	Drug substance, Drug product	2021-10-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215310-001	9796712	2035-05-13		Drug substance, Drug product	2021-10-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215310-001	10227342	2035-05-13	U-3220	Drug substance, Drug product	2021-10-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215310-001	9796712	2035-05-13		Drug substance, Drug product	2021-10-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215310-001	10227342	2035-05-13	U-3220	Drug substance, Drug product	2021-10-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215310-001	9796712	2035-05-13		Drug substance, Drug product	2021-10-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215310-001	10227342	2035-05-13	U-3220	Drug substance, Drug product	2021-10-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215310-001	9796712	2035-05-13		Drug substance, Drug product	2021-10-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215310-001	10227342	2035-05-13	U-3220	Drug substance, Drug product	2021-10-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215310-001	9796712	2035-05-13		Drug substance, Drug product	2021-10-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215310-001	10227342	2035-05-13	U-3220	Drug substance, Drug product	2021-10-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215310-001	9796712	2035-05-13		Drug substance, Drug product	2021-10-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215310-001	10227342	2035-05-13	U-3220	Drug substance, Drug product	2021-10-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215310-001	9796712	2035-05-13		Drug substance, Drug product	2021-10-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215310-001	10227342	2035-05-13	U-3220	Drug substance, Drug product	2021-10-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215310-001	9796712	2035-05-13		Drug substance, Drug product	2021-10-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215310-001	10227342	2035-05-13	U-3220	Drug substance, Drug product	2021-10-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215310-001	9796712	2035-05-13		Drug substance, Drug product	2021-10-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215310-001	10227342	2035-05-13	U-3220	Drug substance, Drug product	2021-10-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N215310-001	9796712	2035-05-13		Drug substance, Drug product	2021-10-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215310-001	10227342	2035-05-13	U-3220	Drug substance, Drug product	2021-10-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215310-001	9796712	2035-05-13		Drug substance, Drug product	2021-10-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215310-001	10227342	2035-05-13	U-3220	Drug substance, Drug product	2021-10-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N215310-001	9796712	2035-05-13		Drug substance, Drug product	2021-10-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N215310-001	10227342	2035-05-13	U-3220	Drug substance, Drug product	2021-10-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N215310-001	9796712	2035-05-13		Drug substance, Drug product	2021-10-05	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N215310-001	10227342	2035-05-13	U-3220	Drug substance, Drug product	2021-10-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N215310-001	9796712	2035-05-13		Drug substance, Drug product	2021-10-05	`bb7c543d1eb4…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 69 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	N215310-001	NCE	2026-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215310-001	ODE-374	2028-09-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215310-001	NCE	2026-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215310-001	ODE-374	2028-09-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215310-001	NCE	2026-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215310-001	ODE-374	2028-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215310-001	NCE	2026-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215310-001	ODE-374	2028-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215310-001	NCE	2026-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215310-001	ODE-374	2028-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215310-001	NCE	2026-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215310-001	ODE-374	2028-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215310-001	NCE	2026-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215310-001	ODE-374	2028-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215310-001	NCE	2026-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215310-001	ODE-374	2028-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215310-001	NCE	2026-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215310-001	ODE-374	2028-09-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215310-001	NCE	2026-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215310-001	ODE-374	2028-09-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215310-001	NCE	2026-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215310-001	ODE-374	2028-09-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215310-001	NCE	2026-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215310-001	ODE-374	2028-09-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215310-001	NCE	2026-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215310-001	ODE-374	2028-09-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215310-001	NCE	2026-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215310-001	ODE-374	2028-09-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215310-001	NCE	2026-09-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215310-001	ODE-374	2028-09-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215310-001	NCE	2026-09-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N215310-001	ODE-374	2028-09-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215310-001	NCE	2026-09-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215310-001	ODE-374	2028-09-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215310-001	NCE	2026-09-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N215310-001	ODE-374	2028-09-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N215310-001	NCE	2026-09-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N215310-001	ODE-374	2028-09-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N215310-001	NCE	2026-09-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N215310-001	ODE-374	2028-09-15	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63020-040-12	2025-02-03	These highlights do not include all the information needed to use EXKIVITY safely and effectively. See full prescribing information for EXKIVITY. EXKIVITY ® (mobocertinib) capsules, for oral use Initial U.S. Approval: 2021
63020-040-90	2025-02-03	These highlights do not include all the information needed to use EXKIVITY safely and effectively. See full prescribing information for EXKIVITY. EXKIVITY ® (mobocertinib) capsules, for oral use Initial U.S. Approval: 2021
63020-040-12	2025-01-30	These highlights do not include all the information needed to use EXKIVITY safely and effectively. See full prescribing information for EXKIVITY. EXKIVITY ® (mobocertinib) capsules, for oral use Initial U.S. Approval: 2021
63020-040-90	2025-01-30	These highlights do not include all the information needed to use EXKIVITY safely and effectively. See full prescribing information for EXKIVITY. EXKIVITY ® (mobocertinib) capsules, for oral use Initial U.S. Approval: 2021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63020-040-12	EA - Each	63020-040	15e1e47a-9dc1-4a6e-a230-84f7704c1a8b	1	2021-10-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63020-040-12	63020004012	120 CAPSULE in 1 BOTTLE (63020-040-12)	120 capsule	2021-09-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
EXKIVITY	Takeda Pharmaceuticals America, Inc. \| AndersonBrecon Inc. \| Takeda Ireland Limited \| Lonza Tampa LLC \| Eurofins Lancaster Laboratories, Inc. \| Ash Stevens LLC \| Catalent Micron Technologies, Inc.	2025-02-03	HUMAN PRESCRIPTION DRUG LABEL	5