FDA.reportPublic FDA data

NDC 0006-4094-01 - 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
0006-4094
Requested NDC
0006-4094-01
Package NDCs from labels
0006-4094-01, 0006-4094-02
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-4094-01RECOMBIVAX HB1 mL in 1 SYRINGEINJECTION, SUSPENSION132
0006-4094-02RECOMBIVAX HB10 in 1 CARTONINJECTION, SUSPENSION1032

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-4094RECOMBIVAX 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
0006-4094-01ML - Milliliter0006-4094c25a9048-31c0-4d85-96d8-e7607da545a812014-08-01
0006-4094-02ML - Milliliter0006-409449491561-33fe-4edc-8516-315aed238ae312014-08-01
0006-4094-09ML - Milliliter0006-409481959c94-7e44-4807-9dec-426df875a25412013-02-13

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 2 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INVANZERTAPENEM SODIUMMerck Sharp & Dohme LLC33f3b99b-fa82-42e0-26bf-f49891ae3d222026-02-04Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
VERQUVOVERICIGUATMerck Sharp & Dohme LLC17056d73-1b1b-4bf2-9c07-b7a9367f0d6d2026-01-21Boxed warning, Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
PREVYMISLETERMOVIRMerck Sharp & Dohme LLC1b49df80-be4f-47e0-a0b7-123f3e69395b2026-01-14Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
RECARBRIOIMIPENEM ANHYDROUS, CILASTATIN, AND RELEBACTAM ANHYDROUSMerck Sharp & Dohme LLCbe32f468-738b-40df-a425-591e12f651592025-12-09Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
ENFLONSIACLESROVIMABMerck Sharp & Dohme LLCc9004a92-40e8-4cdb-b22d-d07929f8fc3b2025-06-20Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
BELSOMRASUVOREXANTMerck Sharp & Dohme LLCe5b72731-1acb-45b7-9c13-290ad12d39512025-03-10Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
JANUVIASITAGLIPTINMerck Sharp & Dohme LLCf85a48d0-0407-4c50-b0fa-7673a160bf012024-11-14Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
ZINPLAVABEZLOTOXUMABMerck Sharp & Dohme LLC8f479bfe-2bfa-4cc5-9aee-1357364480b02024-11-12Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
ZOLINZAVORINOSTATMerck Sharp & Dohme LLCcd86ee78-2781-468b-930c-3c4677bcc0922024-11-12Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
ISENTRESSRALTEGRAVIRMerck Sharp & Dohme LLC89a5ec53-d956-4329-8004-0f40f51c88a32024-10-18Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
DificidFIDAXOMICINMerck Sharp & Dohme LLCdd966338-c820-4270-b704-09ef75fa3ceb2024-10-16Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
CANCIDASCASPOFUNGIN ACETATEMerck Sharp & Dohme LLC3bad23a6-09a6-4194-9182-093ed61bc71c2024-10-11Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
STROMECTOLIVERMECTINMerck Sharp & Dohme LLC681888c9-af79-4b7d-ae80-c3f4f6f1effd2024-09-20Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
PRIMAXIN IVIMIPENEM AND CILASTATIN SODIUMMerck Sharp & Dohme LLCf41d8abd-7792-4918-1b93-bd83ea01955e2024-07-05Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
EMENDAPREPITANTMerck Sharp & Dohme LLC696f9e80-9cae-403b-de9e-078343ce47132024-07-05Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC

Reported adverse events (FAERS/openFDA)#

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