FDA.reportPublic FDA data

NDC 0006-4981-01 - RECOMBIVAX HB

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0006-4981
Requested NDC
0006-4981-01
Package NDCs from labels
0006-4981-01, 0006-4981-00
Manufacturer
Merck Sharp & Dohme LLC
Effective date
2024-10-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
RECOMBIVAX HB - Merck Sharp & Dohme LLCMerck Sharp & Dohme LLC2024-10-31VACCINE LABEL
RECOMBIVAX HB - A-S Medication SolutionsA-S Medication Solutions2021-06-16VACCINE LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-4981-00RECOMBIVAX HB10 in 1 CARTONINJECTION, SUSPENSION1032
0006-4981-01RECOMBIVAX HB0.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION0.532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-4981RECOMBIVAX HB (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [MERCK SHARP & DOHME LLC]31Current NDC, Legacy NDC, 2 package rows20241109_b5bd99e4-569d-48d5-ba75-16e69f8c409a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-4981-00ML - Milliliter0006-49816342b06a-27fd-4317-b42e-fc503c61ee8412013-02-13
0006-4981-01ML - Milliliter0006-4981afc2b520-4821-4d95-93b9-94b57c2e2a8a12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGENACTIVE INGREDIENTXL4HLC6JH6RECOMBIVAX HB (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]19
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGENACTIVE MOIETYXL4HLC6JH6RECOMBIVAX HB (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]19

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 132 · 2,631 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEA-S Medication Solutions93041e9c-3320-4617-b1c1-68c95bf6b7702026-09-23Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
VareniclineVARENICLINEA-S Medication Solutions09e23664-936d-4c7f-86e5-5f924cb0c8b42026-09-21Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEA-S Medication Solutions29b639e3-25a5-4c2f-b4ea-a119db79fe0c2026-09-09Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
TadalafilTADALAFILA-S Medication Solutionsb1840f16-a7ea-44bd-b091-5268990aedb22026-09-09Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
SENOKOTSTANDARDIZED SENNAA-S Medication Solutions0c6e6bdd-9f49-4550-b60a-8f58b7c0f0902026-09-09WarningsName fallback
manufacturer name: A-S Medication Solutions
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEA-S Medication Solutions2518b0b6-35ab-49f4-936c-1eafea04b4662026-09-09WarningsName fallback
manufacturer name: A-S Medication Solutions
Doxycycline HyclateDOXYCYCLINE HYCLATEA-S Medication Solutions9ecadbc8-3087-4692-916a-b7f392d8e8da2026-09-09Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
TadalafilTADALAFILA-S Medication Solutions81222924-29d9-4031-954d-132923867b8e2026-09-09Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
FenofibrateFENOFIBRATEA-S Medication Solutionsc870ea48-5dde-4a6f-9ddb-56b494bb2b552026-09-09Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
LinezolidLINEZOLIDA-S Medication Solutions3d630d3d-510d-43a4-8703-8b62348315642026-09-03Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutionsb6d7edc9-93d6-4480-906d-55c18d0536002026-09-02Boxed warning, Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutionsd9698809-4887-4514-aa28-0066355ef9082026-09-02Boxed warning, Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
TIMOLOL MALEATETIMOLOL MALEATEA-S Medication Solutions64561dfd-3704-4820-aef6-d0d26cef72552026-09-02Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions64f5b140-7ad8-4c07-bbfc-ae4618afa8502026-09-01Boxed warning, Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
RIZAFILMRIZATRIPTAN BENZOATEA-S Medication Solutions8e36b946-cf2a-44d9-9ba7-4385cfe6b3602026-08-28Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
FenofibrateFENOFIBRATEA-S Medication Solutionsd0c7070e-b3bb-4b5b-8a62-4e3136b5accc2026-08-28Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
TadalafilTADALAFILA-S Medication Solutionscf9431ef-ea02-457d-b83a-ce13fb963d952026-08-28Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
LidocaineLIDOCAINEA-S Medication Solutions3fbe48b5-128a-471c-8ecb-45e903b567402026-08-28Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
EstradiolESTRADIOLA-S Medication Solutionsc8a2d29c-299c-4559-b859-87b303a4af812026-08-28Boxed warning, Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
etodolacETODOLACA-S Medication Solutions1e04a6b7-a671-4999-ab03-aa1a243aac032026-08-28Boxed warning, Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions

Reported adverse events (FAERS/openFDA)#

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