HAVRIX

Product NDC: 55045-3841
11-digit product format: 550453841
Labeler code: 55045
Product ID: 55045-3841_25851d21-e9bb-458f-a820-25f5d01ee97d
Type: VACCINE
Nonproprietary name: Hepatitis A Vaccine
Dosage form: INJECTION, SUSPENSION
Route: INTRAMUSCULAR
Labeler: Dispensing Solutions, Inc.
Application: BLA103475
Marketing category: BLA
Marketing start: 2007-04-13
Marketing end: 0000-00-00
Substance: HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)
Active strength: 1440 [iU]/mL
Pharmacologic classes: Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [CS],Vaccines, Inactivated [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55045-3841-1	2019-11-13	C162847	48780-1	97449f38-d3fd-f6ea-e053-dbdaa90aa703	These highlights do not include all the information needed to use HAVRIX safely and effectively. See full prescribing information for HAVRIX. HAVRIX (Hepatitis A Vaccine) Suspension for Intramuscular Injection Initial U.S. Approval: 1995

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)	ACTIVE INGREDIENT	5BFC8LZ6LQ	HAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]	1
HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)	ACTIVE MOIETY	5BFC8LZ6LQ	HAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]	1
ALUMINUM HYDROXIDE	INACTIVE INGREDIENT	5QB0T2IUN0	HAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	HAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5BFC8LZ6LQ	HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)	467420-42-4	HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)