NDC 68258-8912

HAVRIX

Hepatitis A Vaccine

HAVRIX is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Dispensing Solutions, Inc.. The primary component is Hepatitis A Virus Strain Hm175 Antigen (formaldehyde Inactivated).

• Product ID: 68258-8912_c319ee15-43a9-4864-a4c1-40ffb50d9e5a
• NDC: 68258-8912
• Product Type: Vaccine
• Proprietary Name: HAVRIX
• Generic Name: Hepatitis A Vaccine
• Dosage Form: Injection, Suspension
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2007-04-13
• Marketing Category: BLA / BLA
• Application Number: BLA103475
• Labeler Name: Dispensing Solutions, Inc.
• Substance Name: HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)
• Active Ingredient Strength: 1440 [iU]/mL
• Pharm 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

Packaging

NDC 68258-8912-9

1 mL in 1 VIAL (68258-8912-9)

• Marketing Start Date: 2007-04-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68258-8912-9 [68258891209]

HAVRIX INJECTION, SUSPENSION

• Marketing Category: BLA
• Application Number: BLA103475
• Product Type: VACCINE
• Marketing Start Date: 2007-04-13
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)	1440 [iU]/mL

Pharmacological Class

• Inactivated Hepatitis A Virus Vaccine [EPC]
• Actively Acquired Immunity [PE]
• Hepatitis A Vaccines [CS]
• Vaccines
• Inactivated [CS]

NDC Crossover Matching brand name "HAVRIX" or generic name "Hepatitis A Vaccine"

NDC	Brand Name	Generic Name
50090-1502	HAVRIX	Hepatitis A Vaccine
55045-3841	HAVRIX	Hepatitis A Vaccine
58160-825	HAVRIX	Hepatitis A Vaccine
58160-826	HAVRIX	Hepatitis A Vaccine
68258-8912	HAVRIX	Hepatitis A Vaccine