ENGERIX-B
ENGERIX-B Hepatitis B Vaccine (Recombinant)
Approved
Approval ID
4d930f24-4ddb-488d-9e79-3f495972733b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 2, 2010
Manufacturers
FDA
Dispensing Solutions Inc.
DUNS: 066070785
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hepatitis B Vaccine (Recombinant)
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68258-3042
Application NumberBLA103239
Product Classification
M
Marketing Category
C73585
G
Generic Name
Hepatitis B Vaccine (Recombinant)
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateMarch 2, 2010
FDA Product Classification
INGREDIENTS (5)
HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGENActive
Quantity: 20 ug in 1 mL
Code: 9GCJ1L5D1P
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2T
Classification: IACT
ALUMINUM HYDROXIDEInactive
Code: 5QB0T2IUN0
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Code: 5QWK665956
Classification: IACT