HAVRIX

Product NDC: 68258-8912
11-digit product format: 682588912
Labeler code: 68258
Product ID: 68258-8912_c319ee15-43a9-4864-a4c1-40ffb50d9e5a
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
68258-8912-9	2019-11-27	C162847	48780-1	9855e2a2-3c24-60a7-e053-dbdaa90a05bd	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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68258-8912-9	HAVRIX	1 mL in 1 VIAL	INJECTION, SUSPENSION	1		1

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

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68258-8912	HAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]	1	Legacy NDC, 1 package rows	20131112_135ff1b4-c21f-4df1-97be-9475680e9e44.zip

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)

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1658060	HAVRIX adult vaccine 1440 UNT in 1 ML Injection	PSN	135ff1b4-c21f-4df1-97be-9475680e9e44	1
1658058	hepatitis A vaccine adult (HepA) 1440 UNT in 1 ML Injection	PSN	135ff1b4-c21f-4df1-97be-9475680e9e44	1
1658060	1 ML hepatitis A vaccine (inactivated) strain HM175 1440 UNT/ML Injection [Havrix]	SBD	135ff1b4-c21f-4df1-97be-9475680e9e44	1
1658058	1 ML hepatitis A vaccine (inactivated) strain HM175 1440 UNT/ML Injection	SCD	135ff1b4-c21f-4df1-97be-9475680e9e44	1
1658060	1 ML Havrix 1440 UNT/ML Injection	SY	135ff1b4-c21f-4df1-97be-9475680e9e44	1
1658060	Havrix 1440 UNT per 1 ML Injection	SY	135ff1b4-c21f-4df1-97be-9475680e9e44	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
68258-8912-9	68258891209	1 mL in 1 VIAL	1 ml	Historical