NDC 0006-4995

RECOMBIVAX HB

Hepatitis B Vaccine (recombinant)

RECOMBIVAX HB is a Intramuscular; Subcutaneous Injection, Suspension in the Vaccine category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Hepatitis B Virus Subtype Adw Hbsag Surface Protein Antigen.

• Product ID: 0006-4995_154095f6-aada-4a3f-a0b2-76009c1922e4
• NDC: 0006-4995
• Product Type: Vaccine
• Proprietary Name: RECOMBIVAX HB
• Generic Name: Hepatitis B Vaccine (recombinant)
• Dosage Form: Injection, Suspension
• Route of Administration: INTRAMUSCULAR; SUBCUTANEOUS
• Marketing Start Date: 1986-07-23
• Marketing Category: BLA / BLA
• Application Number: BLA101066
• Labeler Name: Merck Sharp & Dohme Corp.
• Substance Name: HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN
• Active Ingredient Strength: 10 ug/mL
• Pharm Classes: Inactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [CS],Vaccines, Inactivated [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0006-4995-00

1 VIAL, SINGLE-DOSE in 1 CARTON (0006-4995-00) > 1 mL in 1 VIAL, SINGLE-DOSE (0006-4995-01)

• Marketing Start Date: 1986-07-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0006-4995-00 [00006499500]

RECOMBIVAX HB INJECTION, SUSPENSION

• Marketing Category: BLA
• Application Number: BLA101066
• Product Type: VACCINE
• Billing Unit: ML
• Marketing Start Date: 1986-07-23

NDC 0006-4995-01 [00006499501]

RECOMBIVAX HB INJECTION, SUSPENSION

• Marketing Category: BLA
• Application Number: BLA101066
• Product Type: VACCINE
• Billing Unit: ML
• Marketing Start Date: 2013-09-06

NDC 0006-4995-41 [00006499541]

RECOMBIVAX HB INJECTION, SUSPENSION

• Marketing Category: BLA
• Application Number: BLA101066
• Product Type: VACCINE
• Billing Unit: ML
• Marketing Start Date: 1986-07-23

Drug Details

Active Ingredients

Ingredient	Strength
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN	10 ug/mL

Pharmacological Class

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

NDC Crossover Matching brand name "RECOMBIVAX HB" or generic name "Hepatitis B Vaccine (recombinant)"

NDC	Brand Name	Generic Name
0006-4093	RECOMBIVAX HB	Hepatitis B Vaccine (Recombinant)
0006-4094	RECOMBIVAX HB	Hepatitis B Vaccine (Recombinant)
0006-4981	RECOMBIVAX HB	Hepatitis B Vaccine (Recombinant)
0006-4992	RECOMBIVAX HB	Hepatitis B Vaccine (Recombinant)
0006-4995	RECOMBIVAX HB	Hepatitis B Vaccine (Recombinant)
50090-1716	RECOMBIVAX HB	Hepatitis B Vaccine (Recombinant)
50090-1719	RECOMBIVAX HB	Hepatitis B Vaccine (Recombinant)
50090-1849	RECOMBIVAX HB	Hepatitis B Vaccine (Recombinant)
50090-1223	ENGERIX-B	Hepatitis B Vaccine (Recombinant)
50090-1706	ENGERIX-B	Hepatitis B Vaccine (Recombinant)
58160-820	ENGERIX-B	Hepatitis B Vaccine (Recombinant)
58160-821	ENGERIX-B	Hepatitis B Vaccine (Recombinant)