HEPLISAV-B

Product NDC

50090-3469

11-digit product format

500903469

Labeler code

50090

Product ID

50090-3469_83f8cd57-8c8a-476d-95d4-44524e0ebaa2

Type

VACCINE

Nonproprietary name

Hepatitis B Vaccine (Recombinant) Adjuvanted

Dosage form

INJECTION, SOLUTION

Route

INTRAMUSCULAR

Labeler

A-S Medication Solutions

Application

BLA125428

Marketing category

BLA

Marketing start

2018-01-01

Marketing end

0000-00-00

Substance

HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN

Active strength

20 ug/.5mL

Pharmacologic classes

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

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record