IV STABILIZER

Product NDC: 73380-4715
11-digit product format: 733804715
Labeler code: 73380
Product ID: 73380-4715_50a54d82-8f62-4e80-a35f-cd51a48bb0e5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: POLYSORBATE 80
Dosage form: SOLUTION
Route: INTRAVENOUS
Labeler: Innate Pharma, Inc.
Application: BLA761104
Marketing category: BLA
Marketing start: 2020-05-15
Marketing end: 0000-00-00
Substance: POLYSORBATE 80
Active strength: 7 mg/mL
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	73380-4715		I	Inactivated by FDA		2026-07-31
excluded package	package	73380-4715	73380-4715-9	I	Inactivated by FDA		2026-07-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
0645c239-8d92-4c0f-9ec0-962bd0429055	Product name	1	20181220
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
73380-4715-9	2022-01-28	C162847	48780-1	d6a99b39-afef-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use LUMOXITI safely and effectively. See full prescribing information for LUMOXITI. LUMOXITI ® (moxetumomab pasudotox-tdfk) for injection, for intravenous use Initial U.S. Approval: 2018

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73380-4715-9	IV STABILIZER	1 mL in 1 VIAL	SOLUTION	1		2
73380-4715-9	IV STABILIZER	1 in 1 CARTON	SOLUTION	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73380-4715	LUMOXITI (MOXETUMOMAB PASUDOTOX) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION IV STABILIZER (POLYSORBATE 80) SOLUTION [INNATE PHARMA, INC.]	2	Legacy NDC, 2 package rows	20200905_8ddffb08-aab1-41f5-bbc6-09457e4e80ca.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761104	Lumoxiti	moxetumomab pasudotox-tdfk	351(a)	Disc	2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2099314	LUMOXITI 1 MG Injection	PSN	8ddffb08-aab1-41f5-bbc6-09457e4e80ca	2
2099309	moxetumomab pasudotox-tdfk 1 MG Injection	PSN	8ddffb08-aab1-41f5-bbc6-09457e4e80ca	2
2099314	moxetumomab pasudotox-tdfk 1 MG Injection [Lumoxiti]	SBD	8ddffb08-aab1-41f5-bbc6-09457e4e80ca	2
2099309	moxetumomab pasudotox-tdfk 1 MG Injection	SCD	8ddffb08-aab1-41f5-bbc6-09457e4e80ca	2
2099314	Lumoxiti 1 MG Injection	SY	8ddffb08-aab1-41f5-bbc6-09457e4e80ca	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
73380-4715-9	73380471509	1 VIAL in 1 CARTON (73380-4715-9) > 1 mL in 1 VIAL	1 vial	2020-05-15	0000-00-00	No	No	Current