NDC 68258-3042

ENGERIX-B

Hepatitis B Vaccine (recombinant)

ENGERIX-B is a Intramuscular Injection, Suspension in the Human Prescription Drug category. It is labeled and distributed by Dispensing Solutions Inc.. The primary component is Hepatitis B Virus Subtype Adw2 Hbsag Surface Protein Antigen.

• Product ID: 68258-3042_f11aa988-f958-4f75-ab9b-89c24998faff
• NDC: 68258-3042
• Product Type: Human Prescription Drug
• Proprietary Name: ENGERIX-B
• Generic Name: Hepatitis B Vaccine (recombinant)
• Dosage Form: Injection, Suspension
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2009-05-28
• Marketing Category: BLA / BLA
• Application Number: BLA103239
• Labeler Name: Dispensing Solutions Inc.
• Substance Name: HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN
• Active Ingredient Strength: 20 ug/mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 68258-3042-1

1 VIAL in 1 CARTON (68258-3042-1) > 1 mL in 1 VIAL

• Marketing Start Date: 2009-05-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68258-3042-1 [68258304201]

ENGERIX-B INJECTION, SUSPENSION

• Marketing Category: BLA
• Application Number: BLA103239
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-05-28
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

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

OpenFDA Data

• SPL SET ID: 4d930f24-4ddb-488d-9e79-3f495972733b
• Manufacturer:
  • Dispensing Solutions Inc.
• UNII:
  • 9GCJ1L5D1P
• RxNorm Concept Unique ID - RxCUI:
  • 1658157
  • 1658156

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)