NDC 50090-3469

HEPLISAV-B

Hepatitis B Vaccine (recombinant) Adjuvanted

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

• Product ID: 50090-3469_83f8cd57-8c8a-476d-95d4-44524e0ebaa2
• NDC: 50090-3469
• Product Type: Vaccine
• Proprietary Name: HEPLISAV-B
• Generic Name: Hepatitis B Vaccine (recombinant) Adjuvanted
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2018-01-01
• Marketing Category: BLA / BLA
• Application Number: BLA125428
• Labeler Name: A-S Medication Solutions
• Substance Name: HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN
• Active Ingredient Strength: 20 ug/.5mL
• 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: 2019-12-31

Packaging

NDC 50090-3469-0

5 VIAL in 1 CARTON (50090-3469-0) > .5 mL in 1 VIAL (50090-3469-9)

• Marketing Start Date: 2018-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-3469-0 [50090346900]

HEPLISAV-B INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125428
• Product Type: VACCINE
• Billing Unit: ML
• Marketing Start Date: 2018-01-01
• Marketing End Date: 2019-10-17

NDC 50090-3469-9 [50090346909]

HEPLISAV-B INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125428
• Product Type: VACCINE
• Marketing Start Date: 2018-01-01
• Marketing End Date: 2019-10-17

Drug Details

Active Ingredients

Ingredient	Strength
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN	20 ug/.5mL

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
43528-002	HEPLISAV-B	Hepatitis B Vaccine (Recombinant) Adjuvanted
43528-003	HEPLISAV-B	Hepatitis B Vaccine (Recombinant) Adjuvanted
50090-3469	HEPLISAV-B	Hepatitis B Vaccine (Recombinant) Adjuvanted