NDC 50090-1223

ENGERIX-B

Hepatitis B Vaccine (recombinant)

ENGERIX-B is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by A-s Medication Solutions. The primary component is Hepatitis B Virus Subtype Adw2 Hbsag Surface Protein Antigen.

• Product ID: 50090-1223_9f6b2d06-8836-4ed8-8e66-776c370c7079
• NDC: 50090-1223
• Product Type: Vaccine
• Proprietary Name: ENGERIX-B
• Generic Name: Hepatitis B Vaccine (recombinant)
• Dosage Form: Injection, Suspension
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2007-03-28
• Marketing Category: BLA / BLA
• Application Number: BLA103239
• Labeler Name: A-S Medication Solutions
• Substance Name: HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN
• Active Ingredient Strength: 20 ug/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 50090-1223-1

1 SYRINGE in 1 POUCH (50090-1223-1) > 1 mL in 1 SYRINGE

• Marketing Start Date: 2007-03-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-1223-9 [50090122309]

ENGERIX-B INJECTION, SUSPENSION

• Marketing Category: BLA
• Application Number: BLA103239
• Product Type: VACCINE
• Marketing Start Date: 2007-03-28

NDC 50090-1223-1 [50090122301]

ENGERIX-B INJECTION, SUSPENSION

• Marketing Category: BLA
• Application Number: BLA103239
• Product Type: VACCINE
• Billing Unit: ML
• Marketing Start Date: 2007-03-28
• Inactivation Date: 2020-01-31

NDC 50090-1223-0 [50090122300]

ENGERIX-B INJECTION, SUSPENSION

• Marketing Category: BLA
• Application Number: BLA103239
• Product Type: VACCINE
• Billing Unit: ML
• Marketing Start Date: 2007-03-28
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN	20 ug/mL

NDC Crossover Matching brand name "ENGERIX-B" or generic name "Hepatitis B Vaccine (recombinant)"

NDC	Brand Name	Generic Name
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)
68258-3042	ENGERIX-B	ENGERIX-B
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)