FDA.reportPublic FDA data

NDC 0006-4995-01 - 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
0006-4995
Requested NDC
0006-4995-01
Package NDCs from labels
0006-4995-01, 0006-4995-41, 0006-4995-00
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
RECOMBIVAX HB - A-S Medication SolutionsA-S Medication Solutions2021-06-16VACCINE LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-4995-00RECOMBIVAX HB1 in 1 CARTONINJECTION, SUSPENSION132
0006-4995-01RECOMBIVAX HB1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION132
0006-4995-41RECOMBIVAX HB10 in 1 CARTONINJECTION, SUSPENSION1032

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-4995RECOMBIVAX HB (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [MERCK SHARP & DOHME LLC]31Current NDC, Legacy NDC, 3 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
0006-4995-00ML - Milliliter0006-4995bf106525-0ae5-40e6-90c5-7059dfdfa0d012013-02-13
0006-4995-01ML - Milliliter0006-4995a28f5e9f-b2b7-4304-a4a5-cb622bcfdf6a12019-08-06
0006-4995-41ML - Milliliter0006-4995b542a0f0-6d19-4700-a29c-64896f7ac78b12013-02-13

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 132 · 2,631 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEA-S Medication Solutions7cb4879f-31e7-4862-bc0c-d439e592d81c2026-08-28Boxed warning, Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
MethotrexateMETHOTREXATEA-S Medication Solutions22e10810-16fb-4c84-bccf-972405b77ef82026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
CelecoxibCELECOXIBA-S Medication Solutionse84d67c8-010d-495c-8691-ae16d0698f8d2026-08-25Boxed warning, Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
TadalafilTADALAFILA-S Medication Solutionsa6847ad6-3b5b-47e5-a3b5-04dc3182d72b2026-08-25Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions4937611d-bd61-4538-ad1e-bd67e95279552026-08-25Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
Lidocaine 5%LIDOCAINE 5%A-S Medication Solutionsfec1e759-60e4-47d4-bd54-947f18b103dd2026-08-25Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEA-S Medication Solutions59cc61da-838e-4add-b2d6-42b2b283a0002026-08-20Boxed warning, Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
CefdinirCEFDINIRA-S Medication Solutions0eeac6df-bad7-413e-8b41-0660f3a993732026-08-20Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions12ba7eba-1874-41b6-aff5-7baba8b999842026-08-20Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutionse0d5b1f6-c1f2-4d5b-a1c3-aebe77843df22026-08-18Boxed warning, Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEA-S Medication Solutions0516d548-db9b-410a-aec9-79aedbc3f6e92026-08-18Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEA-S Medication Solutionsed182ebe-8299-4680-9dea-ef79d30db6832026-08-18Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
SEGLUROMETERTUGLIFLOZIN AND METFORMIN HYDROCHLORIDEMerck Sharp & Dohme LLCa6aeb99a-ce49-4125-90ce-642df3f1ebad2026-08-11Boxed warning, Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
JANUMET XRSITAGLIPTIN AND METFORMIN HYDROCHLORIDEMerck Sharp & Dohme LLC64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b502026-08-11Boxed warning, Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
JANUMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEMerck Sharp & Dohme LLCd19c7ed0-ad5c-426e-b2df-722508f97d672026-08-11Boxed warning, Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
AmoxicillinAMOXICILLINA-S Medication Solutions452eb254-028a-4e02-9cb0-85483a4abaf52026-08-10Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
SildenafilSILDENAFILA-S Medication Solutionsdc38f412-dca7-4b54-b14c-314e7a251ee62026-08-10Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
Mycophenolate MofetilMYCOPHENOLATE MOFETILA-S Medication Solutionsb4170ad9-67f0-42ea-b694-6b80824a607a2026-08-10Boxed warning, Warnings, Adverse reactionsName fallback
manufacturer name: A-S Medication Solutions
Bacitracin ZincBACITRACIN ZINCA-S Medication Solutions9fcda25b-3940-4028-a8ee-6e6c6e4b2a532026-08-07WarningsName fallback
manufacturer name: A-S Medication Solutions
CelecoxibCELECOXIBA-S Medication Solutionsd799328f-9ea0-4b64-9667-8feaa97f150c2026-08-07Boxed 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.