KOSELUGO

Product NDC: 0310-0610
11-digit product format: 003100610
Labeler code: 0310
Product ID: 0310-0610_b3809b9c-c5d0-44c6-9c21-abcc230f64ac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SELUMETINIB
Dosage form: CAPSULE
Route: ORAL
Labeler: AstraZeneca Pharmaceuticals LP
Application: NDA213756
Marketing category: NDA
Marketing start: 2020-04-16
Substance: SELUMETINIB
Active strength: 10 mg/1
Pharmacologic classes: Kinase Inhibitor [EPC], Mitogen-Activated Protein Kinase Kinase 1 Inhibitors [MoA], Mitogen-Activated Protein Kinase Kinase 2 Inhibitors [MoA]
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N213756-001	KOSELUGO	SELUMETINIB SULFATE	EQ 10MG BASE	CAPSULE / ORAL		RLD	2020-04-10
N213756-002	KOSELUGO	SELUMETINIB SULFATE	EQ 25MG BASE	CAPSULE / ORAL		RLD, RS	2020-04-10

Orange Book patents#

Current patent rows page 1 of 1 · 16 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213756-001	8178693	2026-03-13		Drug substance, Drug product	2020-05-06
N213756-001	9156795	2026-12-12		Drug substance, Drug product	2020-05-06
N213756-001	9562017	2026-12-12	U-4357	Drug substance	2020-05-06
N213756-001	7425637	2028-03-13		Drug substance	2020-05-06
N213756-001	11813246	2029-03-26		Drug product	2023-12-07
N213756-001	12220403	2029-03-26		Drug product	2025-02-14
N213756-001	12318367	2029-03-26		Drug product	2025-07-01
N213756-001	12364684	2029-03-26	U-4357		2025-08-19
N213756-002	8178693	2026-03-13		Drug substance, Drug product	2020-05-06
N213756-002	9156795	2026-12-12		Drug substance, Drug product	2020-05-06
N213756-002	9562017	2026-12-12	U-4357	Drug substance	2020-05-06
N213756-002	7425637	2028-03-13		Drug substance	2020-05-06
N213756-002	11813246	2029-03-26		Drug product	2023-12-07
N213756-002	12220403	2029-03-26		Drug product	2025-02-14
N213756-002	12318367	2029-03-26		Drug product	2025-07-01
N213756-002	12364684	2029-03-26	U-4357		2025-08-19

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 8 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213756-001	ODE-288	2027-04-10
N213756-001	NPP	2028-09-10
N213756-001	NPP	2028-11-19
N213756-001	ODE-545	2032-11-19
N213756-002	ODE-288	2027-04-10
N213756-002	NPP	2028-09-10
N213756-002	NPP	2028-11-19
N213756-002	ODE-545	2032-11-19

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 2 · 74 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	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`87673890dc5c…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 354 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	N213756-001	8178693	2026-03-13		Drug substance, Drug product	2020-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-001	9156795	2026-12-12		Drug substance, Drug product	2020-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-001	9562017	2026-12-12	U-4357	Drug substance	2020-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-001	7425637	2028-03-13		Drug substance	2020-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-001	11813246	2029-03-26		Drug product	2023-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-001	12220403	2029-03-26		Drug product	2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-001	12318367	2029-03-26		Drug product	2025-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-001	12364684	2029-03-26	U-4357		2025-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-002	8178693	2026-03-13		Drug substance, Drug product	2020-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-002	9156795	2026-12-12		Drug substance, Drug product	2020-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-002	9562017	2026-12-12	U-4357	Drug substance	2020-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-002	7425637	2028-03-13		Drug substance	2020-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-002	11813246	2029-03-26		Drug product	2023-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-002	12220403	2029-03-26		Drug product	2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-002	12318367	2029-03-26		Drug product	2025-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-002	12364684	2029-03-26	U-4357		2025-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-001	7425637	2026-03-13		Drug substance	2020-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-001	8178693	2026-03-13		Drug substance, Drug product	2020-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-001	9156795	2026-12-12		Drug substance, Drug product	2020-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-001	9562017	2026-12-12	U-4274	Drug substance	2020-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-001	11813246	2029-03-26		Drug product	2023-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-001	12220403	2029-03-26		Drug product	2025-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-001	12318367	2029-03-26		Drug product	2025-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-001	12364684	2029-03-26	U-4274		2025-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-002	7425637	2026-03-13		Drug substance	2020-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-002	8178693	2026-03-13		Drug substance, Drug product	2020-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-002	9156795	2026-12-12		Drug substance, Drug product	2020-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-002	9562017	2026-12-12	U-4274	Drug substance	2020-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-002	11813246	2029-03-26		Drug product	2023-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-002	12220403	2029-03-26		Drug product	2025-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-002	12318367	2029-03-26		Drug product	2025-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-002	12364684	2029-03-26	U-4274		2025-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213756-001	7425637	2026-03-13		Drug substance	2020-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213756-001	8178693	2026-03-13		Drug substance, Drug product	2020-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213756-001	9156795	2026-12-12		Drug substance, Drug product	2020-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213756-001	9562017	2026-12-12	U-2800	Drug substance	2020-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213756-001	11813246	2029-03-26		Drug product	2023-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213756-001	12220403	2029-03-26		Drug product	2025-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213756-001	12318367	2029-03-26		Drug product	2025-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213756-002	7425637	2026-03-13		Drug substance	2020-05-06	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 156 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213756-001	ODE-288	2027-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-001	NPP	2028-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-001	NPP	2028-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-002	ODE-288	2027-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-002	NPP	2028-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-002	NPP	2028-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-001	NCE	2025-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-001	ODE-288	2027-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-001	NPP	2028-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-002	NCE	2025-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-002	ODE-288	2027-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-002	NPP	2028-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213756-001	NCE	2025-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213756-001	ODE-288	2027-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213756-002	NCE	2025-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213756-002	ODE-288	2027-04-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213756-001	NCE	2025-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213756-001	ODE-288	2027-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213756-002	NCE	2025-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213756-002	ODE-288	2027-04-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213756-001	NCE	2025-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213756-001	ODE-288	2027-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213756-002	NCE	2025-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213756-002	ODE-288	2027-04-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213756-001	NCE	2025-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213756-001	ODE-288	2027-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213756-002	NCE	2025-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213756-002	ODE-288	2027-04-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213756-001	NCE	2025-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213756-001	ODE-288	2027-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213756-002	NCE	2025-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213756-002	ODE-288	2027-04-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213756-001	NCE	2025-04-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213756-001	ODE-288	2027-04-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213756-002	NCE	2025-04-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213756-002	ODE-288	2027-04-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213756-001	NCE	2025-04-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213756-001	ODE-288	2027-04-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213756-002	NCE	2025-04-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213756-002	ODE-288	2027-04-10	`d8e5a09893c0…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SELUMETINIB	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6UH91I579U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2289418	Internal RxNorm lookup
2289424	Internal RxNorm lookup
2289426	Internal RxNorm lookup
2289428	Internal RxNorm lookup
2723653	Internal RxNorm lookup
2723657	Internal RxNorm lookup
2723659	Internal RxNorm lookup
2723661	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
7d042c61-f28f-4ab5-ab10-d7558c0d49ff	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
8ba1a9aa-3486-4082-812d-f96073e22305	Product name	1	20200504
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0310-0610-28	KOSELUGO	28 in 1 BOTTLE	CAPSULE	28		16
0310-0610-60	KOSELUGO	60 in 1 BOTTLE	CAPSULE	60		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0310-0610-28	EA - Each	0310-0610	76b218e2-5e88-42a0-94f8-13b0f47424ce	1	2021-06-02
0310-0610-60	EA - Each	0310-0610	6d8b71cb-6a15-4265-b57f-a121c946900d	1	2020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0310-0610	KOSELUGO (SELUMETINIB) CAPSULE [ASTRAZENECA PHARMACEUTICALS LP]	10	Current NDC, Legacy NDC, 2 package rows	20240601_7d042c61-f28f-4ab5-ab10-d7558c0d49ff.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
KOSELUGO	SELUMETINIB	AstraZeneca Pharmaceuticals LP	7d042c61-f28f-4ab5-ab10-d7558c0d49ff	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213756 application number: NDA213756 ndc (product): 0310-0610

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6UH91I579U	SELUMETINIB	606143-52-6	SELUMETINIB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2289424	Koselugo 10 MG Oral Capsule	PSN	7d042c61-f28f-4ab5-ab10-d7558c0d49ff	17
2289428	Koselugo 25 MG Oral Capsule	PSN	7d042c61-f28f-4ab5-ab10-d7558c0d49ff	17
2723657	Koselugo 5 MG Oral Granules	PSN	7d042c61-f28f-4ab5-ab10-d7558c0d49ff	17
2723661	Koselugo 7.5 MG Oral Granules	PSN	7d042c61-f28f-4ab5-ab10-d7558c0d49ff	17
2289418	selumetinib 10 MG Oral Capsule	PSN	7d042c61-f28f-4ab5-ab10-d7558c0d49ff	17
2289426	selumetinib 25 MG Oral Capsule	PSN	7d042c61-f28f-4ab5-ab10-d7558c0d49ff	17
2723653	selumetinib 5 MG Oral Granules	PSN	7d042c61-f28f-4ab5-ab10-d7558c0d49ff	17
2723659	selumetinib 7.5 MG Oral Granules	PSN	7d042c61-f28f-4ab5-ab10-d7558c0d49ff	17
2289424	selumetinib 10 MG Oral Capsule [Koselugo]	SBD	7d042c61-f28f-4ab5-ab10-d7558c0d49ff	17
2289428	selumetinib 25 MG Oral Capsule [Koselugo]	SBD	7d042c61-f28f-4ab5-ab10-d7558c0d49ff	17
2723657	selumetinib 5 MG Oral Granules [Koselugo]	SBD	7d042c61-f28f-4ab5-ab10-d7558c0d49ff	17
2723661	selumetinib 7.5 MG Oral Granules [Koselugo]	SBD	7d042c61-f28f-4ab5-ab10-d7558c0d49ff	17
2289418	selumetinib 10 MG Oral Capsule	SCD	7d042c61-f28f-4ab5-ab10-d7558c0d49ff	17
2289426	selumetinib 25 MG Oral Capsule	SCD	7d042c61-f28f-4ab5-ab10-d7558c0d49ff	17
2723653	selumetinib 5 MG Oral Granules	SCD	7d042c61-f28f-4ab5-ab10-d7558c0d49ff	17
2723659	selumetinib 7.5 MG Oral Granules	SCD	7d042c61-f28f-4ab5-ab10-d7558c0d49ff	17
2289424	Koselugo 10 MG Oral Capsule	SY	7d042c61-f28f-4ab5-ab10-d7558c0d49ff	17
2289428	Koselugo 25 MG Oral Capsule	SY	7d042c61-f28f-4ab5-ab10-d7558c0d49ff	17
2723657	Koselugo 5 MG Oral Granules	SY	7d042c61-f28f-4ab5-ab10-d7558c0d49ff	17
2723661	Koselugo 7.5 MG Oral Granules	SY	7d042c61-f28f-4ab5-ab10-d7558c0d49ff	17
2289418	selumetinib (as selumetinib sulfate) 10 MG Oral Capsule	SY	7d042c61-f28f-4ab5-ab10-d7558c0d49ff	17
2289426	selumetinib (as selumetinib sulfate) 25 MG Oral Capsule	SY	7d042c61-f28f-4ab5-ab10-d7558c0d49ff	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0310-0610-28	00310061028	28 CAPSULE in 1 BOTTLE (0310-0610-28)	28 capsule	2021-06-11	0000-00-00	No	No	Current
0310-0610-60	00310061060	60 CAPSULE in 1 BOTTLE (0310-0610-60)	60 capsule	2020-04-16	0000-00-00	No	No	Current