NINLARO

Product NDC: 63020-079
Requested package NDC: 63020-079-02
11-digit product format: 630200079
Labeler code: 63020
Product ID: 63020-079_36c4c203-9566-4851-863c-ab7b786e9af5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ixazomib
Dosage form: CAPSULE
Route: ORAL
Labeler: Millennium Pharmaceuticals, Inc.
Application: NDA208462
Marketing category: NDA
Marketing start: 2015-11-20
Marketing end: 0000-00-00
Substance: IXAZOMIB CITRATE
Active strength: 3 mg/1
Pharmacologic classes: Proteasome Inhibitor [EPC],Proteasome Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	63020-079	63020-079-02	D	Discontinued by firm		2026-08-11

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63020-079-02	2021-02-19	C162847	48780-1	ba0f9c33-49d7-a910-e053-dadaa90a0b85	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
63020-079-02	2021-01-29	C162847	48780-1	ba0f9c33-49d7-a910-e053-dadaa90a0b85	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63020-079-01	EA - Each	63020-079	463d9c53-08f5-4968-a7d1-fa2da024cdc8	1	2016-01-13
63020-079-02	EA - Each	63020-079	3eaaa468-f140-4115-8505-61f89c81256b	1	2016-01-13

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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63020-079-02	63020007902	3 BLISTER PACK in 1 CARTON (63020-079-02) > 1 CAPSULE in 1 BLISTER PACK (63020-079-01)	3 blister pack	2015-11-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NINLARO	Takeda Pharmaceuticals America, Inc. \| Ash Stevens Inc. \| AMRI SSCI, LLC \| Eurofins Lancaster Laboratories, Inc. \| Haupt Pharma Amareg GmbH \| AndersonBrecon (UK) Limited \| Microchem Laboratories (Ireland), Ltd \| Takeda Ireland Ltd.	2023-02-22	HUMAN PRESCRIPTION DRUG LABEL	8