NINLARO

Product NDC: 63020-230
11-digit product format: 630200230
Labeler code: 63020
Product ID: 63020-230_16e9f7cd-6a19-4ad1-9431-8205898a33f1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ixazomib
Dosage form: CAPSULE
Route: ORAL
Labeler: Takeda Pharmaceuticals America, Inc.
Application: NDA208462
Marketing category: NDA
Marketing start: 2015-11-20
Substance: IXAZOMIB CITRATE
Active strength: 2.3 mg/1
Pharmacologic classes: Proteasome Inhibitor [EPC], Proteasome 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N208462-001	NINLARO	IXAZOMIB CITRATE	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20
N208462-002	NINLARO	IXAZOMIB CITRATE	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20
N208462-003	NINLARO	IXAZOMIB CITRATE	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20

Orange Book patents#

Current patent rows page 1 of 1 · 21 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208462-001	7687662	2027-08-06		Drug substance, Drug product	2015-12-14
N208462-001	8003819	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14
N208462-001	8530694	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14
N208462-001	8871745	2027-08-06	U-2434		2015-12-14
N208462-001	8859504	2029-06-16		Drug substance, Drug product	2015-12-14
N208462-001	9175017	2029-06-16	U-2434		2015-12-14
N208462-001	7442830	2029-11-20	U-2434	Drug substance, Drug product	2015-12-14
N208462-002	7687662	2027-08-06		Drug substance, Drug product	2015-12-14
N208462-002	8003819	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14
N208462-002	8530694	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14
N208462-002	8871745	2027-08-06	U-2434		2015-12-14
N208462-002	8859504	2029-06-16		Drug substance, Drug product	2015-12-14
N208462-002	9175017	2029-06-16	U-2434		2015-12-14
N208462-002	7442830	2029-11-20	U-2434	Drug substance, Drug product	2015-12-14
N208462-003	7687662	2027-08-06		Drug substance, Drug product	2015-12-14
N208462-003	8003819	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14
N208462-003	8530694	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14
N208462-003	8871745	2027-08-06	U-2434		2015-12-14
N208462-003	8859504	2029-06-16		Drug substance, Drug product	2015-12-14
N208462-003	9175017	2029-06-16	U-2434		2015-12-14
N208462-003	7442830	2029-11-20	U-2434	Drug substance, Drug product	2015-12-14

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	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 27 · 1,071 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	N208462-001	7687662	2027-08-06		Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-001	8003819	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-001	8530694	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-001	8871745	2027-08-06	U-2434		2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-001	8859504	2029-06-16		Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-001	9175017	2029-06-16	U-2434		2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-001	7442830	2029-11-20	U-2434	Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-002	7687662	2027-08-06		Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-002	8003819	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-002	8530694	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-002	8871745	2027-08-06	U-2434		2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-002	8859504	2029-06-16		Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-002	9175017	2029-06-16	U-2434		2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-002	7442830	2029-11-20	U-2434	Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-003	7687662	2027-08-06		Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-003	8003819	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-003	8530694	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-003	8871745	2027-08-06	U-2434		2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-003	8859504	2029-06-16		Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-003	9175017	2029-06-16	U-2434		2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-003	7442830	2029-11-20	U-2434	Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-001	7687662	2027-08-06		Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-001	8003819	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-001	8530694	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-001	8871745	2027-08-06	U-2434		2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-001	8859504	2029-06-16		Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-001	9175017	2029-06-16	U-2434		2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-001	7442830	2029-11-20	U-2434	Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-002	7687662	2027-08-06		Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-002	8003819	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-002	8530694	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-002	8871745	2027-08-06	U-2434		2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-002	8859504	2029-06-16		Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-002	9175017	2029-06-16	U-2434		2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-002	7442830	2029-11-20	U-2434	Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-003	7687662	2027-08-06		Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-003	8003819	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-003	8530694	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-003	8871745	2027-08-06	U-2434		2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-003	8859504	2029-06-16		Drug substance, Drug product	2015-12-14	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208462-001	ODE-103	2022-11-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208462-002	ODE-103	2022-11-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208462-003	ODE-103	2022-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208462-001	ODE-103	2022-11-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208462-002	ODE-103	2022-11-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208462-003	ODE-103	2022-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208462-001	ODE-103	2022-11-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208462-002	ODE-103	2022-11-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208462-003	ODE-103	2022-11-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208462-001	NCE	2020-11-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208462-001	ODE-103	2022-11-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208462-002	NCE	2020-11-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208462-002	ODE-103	2022-11-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208462-003	NCE	2020-11-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208462-003	ODE-103	2022-11-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208462-001	ODE-103	2022-11-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208462-002	ODE-103	2022-11-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208462-003	ODE-103	2022-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208462-001	ODE-103	2022-11-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208462-002	ODE-103	2022-11-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208462-003	ODE-103	2022-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208462-001	ODE-103	2022-11-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208462-002	ODE-103	2022-11-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208462-003	ODE-103	2022-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208462-001	ODE-103	2022-11-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208462-002	ODE-103	2022-11-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208462-003	ODE-103	2022-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208462-001	NCE	2020-11-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208462-001	ODE-103	2022-11-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208462-002	NCE	2020-11-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208462-002	ODE-103	2022-11-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208462-003	NCE	2020-11-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208462-003	ODE-103	2022-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208462-001	NCE	2020-11-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208462-001	ODE-103	2022-11-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208462-002	NCE	2020-11-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208462-002	ODE-103	2022-11-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208462-003	NCE	2020-11-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208462-003	ODE-103	2022-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208462-001	NCE	2020-11-20	`3f01610625f2…`

Additional Listing Data#

Finished product: Yes
Brand name base: NINLARO
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IXAZOMIB CITRATE	2.3 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
46CWK97Z3K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1723757	Internal RxNorm lookup
1723763	Internal RxNorm lookup
1723765	Internal RxNorm lookup
1723767	Internal RxNorm lookup
1723770	Internal RxNorm lookup
1723772	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
038f2461-834b-4488-9ebd-863c83eef5a7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
e65a2211-20c4-4e19-9563-61fcdff0377d	Product name	1	20151215

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63020-230-01	2025-08-18	These highlights do not include all the information needed to use NINLARO safely and effectively. See full prescribing information for NINLARO. NINLARO ® (ixazomib) capsules, for oral use Initial U.S. Approval: 2015
63020-230-02	2025-08-18	These highlights do not include all the information needed to use NINLARO safely and effectively. See full prescribing information for NINLARO. NINLARO ® (ixazomib) capsules, for oral use Initial U.S. Approval: 2015
63020-230-01	2025-07-29	These highlights do not include all the information needed to use NINLARO safely and effectively. See full prescribing information for NINLARO. NINLARO ® (ixazomib) capsules, for oral use Initial U.S. Approval: 2015
63020-230-02	2025-07-29	These highlights do not include all the information needed to use NINLARO safely and effectively. See full prescribing information for NINLARO. NINLARO ® (ixazomib) capsules, for oral use Initial U.S. Approval: 2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63020-230-01	NINLARO	1 in 1 BLISTER PACK	CAPSULE	1	16
63020-230-02	NINLARO	1 in 1 CARTON	CAPSULE	1	16
63020-230-03	NINLARO	3 in 1 BLISTER PACK	CAPSULE	3	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63020-230-01	EA - Each	63020-230	603e9b13-b34c-4685-8f6a-01988c2a0134	1	2021-01-08
63020-230-02	EA - Each	63020-230	50638c2f-72eb-47ca-a202-462c0dc10b2d	1	2021-01-08
63020-230-03	EA - Each	63020-230	13a3e51a-8952-4799-a1b7-79558ea9d4c5	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63020-230	NINLARO (IXAZOMIB) CAPSULE [TAKEDA PHARMACEUTICALS AMERICA, INC.]	14	Current NDC, Legacy NDC, 3 package rows	20240911_038f2461-834b-4488-9ebd-863c83eef5a7.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
NINLARO	IXAZOMIB	Takeda Pharmaceuticals America, Inc.	038f2461-834b-4488-9ebd-863c83eef5a7	2025-08-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208462 application number: NDA208462 ndc (product): 63020-230

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
46CWK97Z3K	IXAZOMIB CITRATE	1239908-20-3	IXAZOMIB CITRATE
71050168A2	IXAZOMIB	1072833-77-2	ixazomib

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1723757	ixazomib 2.3 MG Oral Capsule	PSN	038f2461-834b-4488-9ebd-863c83eef5a7	16
1723765	ixazomib 3 MG Oral Capsule	PSN	038f2461-834b-4488-9ebd-863c83eef5a7	16
1723770	ixazomib 4 MG Oral Capsule	PSN	038f2461-834b-4488-9ebd-863c83eef5a7	16
1723763	NINLARO 2.3 MG Oral Capsule	PSN	038f2461-834b-4488-9ebd-863c83eef5a7	16
1723767	NINLARO 3 MG Oral Capsule	PSN	038f2461-834b-4488-9ebd-863c83eef5a7	16
1723772	NINLARO 4 MG Oral Capsule	PSN	038f2461-834b-4488-9ebd-863c83eef5a7	16
1723763	ixazomib 2.3 MG Oral Capsule [Ninlaro]	SBD	038f2461-834b-4488-9ebd-863c83eef5a7	16
1723767	ixazomib 3 MG Oral Capsule [Ninlaro]	SBD	038f2461-834b-4488-9ebd-863c83eef5a7	16
1723772	ixazomib 4 MG Oral Capsule [Ninlaro]	SBD	038f2461-834b-4488-9ebd-863c83eef5a7	16
1723757	ixazomib 2.3 MG Oral Capsule	SCD	038f2461-834b-4488-9ebd-863c83eef5a7	16
1723765	ixazomib 3 MG Oral Capsule	SCD	038f2461-834b-4488-9ebd-863c83eef5a7	16
1723770	ixazomib 4 MG Oral Capsule	SCD	038f2461-834b-4488-9ebd-863c83eef5a7	16
1723757	ixazomib 2.3 MG (as ixazomib citrate 3.3 MG) Oral Capsule	SY	038f2461-834b-4488-9ebd-863c83eef5a7	16
1723765	ixazomib 3 MG (as ixazomib 4.3 MG) Oral Capsule	SY	038f2461-834b-4488-9ebd-863c83eef5a7	16
1723770	ixazomib 4 MG (as ixazomib citrate 5.7 MG) Oral Capsule	SY	038f2461-834b-4488-9ebd-863c83eef5a7	16
1723763	Ninlaro 2.3 MG (as ixazomib citrate 3.3 MG) Oral Capsule	SY	038f2461-834b-4488-9ebd-863c83eef5a7	16
1723763	Ninlaro 2.3 MG Oral Capsule	SY	038f2461-834b-4488-9ebd-863c83eef5a7	16
1723767	Ninlaro 3 MG (as ixazomib citrate 4.3 MG) Oral Capsule	SY	038f2461-834b-4488-9ebd-863c83eef5a7	16
1723767	Ninlaro 3 MG Oral Capsule	SY	038f2461-834b-4488-9ebd-863c83eef5a7	16
1723772	Ninlaro 4 MG (as ixazomib citrate 5.7 MG) Oral Capsule	SY	038f2461-834b-4488-9ebd-863c83eef5a7	16
1723772	Ninlaro 4 MG Oral Capsule	SY	038f2461-834b-4488-9ebd-863c83eef5a7	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63020-230-01	63020023001	1 CAPSULE in 1 BLISTER PACK (63020-230-01)	1 capsule	2015-11-20		No	No	Current
63020-230-02	63020023002	1 BLISTER PACK in 1 CARTON (63020-230-02) / 3 CAPSULE in 1 BLISTER PACK (63020-230-03)	1 blister pack	2015-11-20	0000-00-00	No	No	Current
63020-230-03	63020023003	3 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NINLARO	Takeda Pharmaceuticals America, Inc. \| Eurofins Lancaster Laboratories, Inc \| AndersonBrecon (UK) Limited \| Eurofins Biopharma Product Testing Ireland Limited \| Almac Sciences Limited	2025-08-18	HUMAN PRESCRIPTION DRUG LABEL	16