FDA.reportPublic FDA data

Hepatitis B Surface Antigen

Manufacturer
Merck Sharp & Dohme Corp.
Effective date
2015-08-05
Label type
LICENSED VACCINE BULK INTERMEDIATE LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:48:05

Label at a glance#

ProductHepatitis B Surface Antigen
Active ingredientHEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN
Label structure1 sections

Label contents#

Full prescribing information#

PRINCIPAL DISPLAY PANEL - Shipping Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HEP B SURFACE ANTIGEN 80MCG/ML
EU

V.1356.29.0002

Material: 2009352
DoM: 15.08.2014

Batch: 0000413893
Expiry: 14.08.2017

Qty:

Rx only. Caution: For manufacturing, processing, or repacking

Storage: (2 °C)-(8 °C)

WEST POINT Mfg. WEST POINT PA 19486-8000 US 215-652-6100

US Gov't Lic No. 0002

MERCK

Shipping Label
Shipping Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69806-0002-0Hepatitis B Surface Antigen37000 g in 1 BOTTLELIQUID370003
69806-0002-0Hepatitis B Surface Antigen1 in 1 CONTAINERLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69806-0002HEPATITIS B SURFACE ANTIGEN (HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN) LIQUID [MERCK SHARP & DOHME CORP.]32 package rows20150903_468b1ba5-371c-4ff0-8565-06482771fc25.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGENACTIVE INGREDIENTXL4HLC6JH63
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGENACTIVE MOIETYXL4HLC6JH63

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69806-000269806-0002-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGENXL4HLC6JH6ACTIB

Source Document#

Source XML · Source PDF

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.