NDC 63020-078-01 - NINLARO

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 63020-078
Requested NDC: 63020-078-01
Package NDCs from labels: 63020-078-01, 63020-078-02
Manufacturer: 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.
Effective date: 2023-02-22
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63020-078-02	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
63020-078-02	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
63020-078-01	EA - Each	63020-078	ef5e9a04-c80a-4aa6-9ce0-8e82ffe3ace6	1	2016-01-13
63020-078-02	EA - Each	63020-078	9f9725f7-a934-45fe-bcda-db9e7b43cdc0	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 · 5 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	2026-08-11	Warnings, Adverse reactions	Exact identifier application number: NDA208462 unii: 46CWK97Z3K
Steritalc 2g	TALC	Novatech SA	c94e51d9-beef-4b06-e053-2a95a90a754a	2025-06-25	Warnings, Adverse reactions	Exact identifier unii: 7SEV7J4R1U
SENSITIVE POCKET SUN	SENSITIVE POCKET SUN	Shantou Oushiya Biotechnology Co., Ltd	36ac412f-e31f-6906-e063-6394a90a4a3d	2025-06-14	Warnings	Exact identifier unii: 7SEV7J4R1U
YVTYVT MICRODERMABRASION FACIAL SCRUB	YVTYVT MICRODERMABRASION FACIAL SCRUB	Beijing JUNGE Technology Co., Ltd.	2f30fc45-42e2-c766-e063-6394a90a8d68	2025-02-28	Warnings	Exact identifier unii: OP1R32D61U
c0bc34d7-e483-4caa-bf57-d8a627b9c20f			fcef9088-ebab-4bd8-933f-c35f9c8bd50b	2023-02-22	Warnings, Adverse reactions	Exact identifier spl id: c0bc34d7-e483-4caa-bf57-d8a627b9c20f spl set id: fcef9088-ebab-4bd8-933f-c35f9c8bd50b

Reported adverse events (FAERS/openFDA)#

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