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 1 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
KEYTRUDA QLEXPEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPHMerck Sharp & Dohme LLC097d166f-b73b-41d3-9b37-7653cd2a0c412026-07-31Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
LIPFENDRALIPFENDRAMerck Sharp & Dohme LLC100ec543-fbd0-44fc-b740-db9cdff391452026-07-15Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
KEYTRUDAPEMBROLIZUMABMerck Sharp & Dohme LLC9333c79b-d487-4538-a9f0-71b91a02b2872026-07-10Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
PIFELTRODORAVIRINEMerck Sharp & Dohme LLC76ce1f00-28c0-4314-bd2c-d473fe3d09702026-07-08Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
DELSTRIGODORAVIRINE, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATEMerck Sharp & Dohme LLCcd1e9f84-607a-46d3-b01e-2736018d67b62026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
STEGLATROERTUGLIFLOZINMerck Sharp & Dohme LLCe6f3e718-bb99-48f1-ab94-b9f0af05fed62026-06-03Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
STEGLUJANERTUGLIFLOZIN AND SITAGLIPTINMerck Sharp & Dohme LLCc2c553d8-5a9d-4366-bf53-8bdb5a876d192026-06-03Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
ZERBAXACEFTOLOZANE AND TAZOBACTAMMerck Sharp & Dohme LLC70ac1d90-eff3-4f0b-9f46-5846c571b32f2026-05-12Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
OhtuvayreENSIFENTRINEMERCK SHARP & DOHME LLCe6433c98-41a0-4f99-8f7f-d0e9db6e3f402026-04-23Warnings, Adverse reactionsName fallback
manufacturer name: MERCK SHARP & DOHME LLC
IDVYNSODORAVIRINE, ISLATRAVIRMerck Sharp & Dohme LLC11aaeb53-9848-433c-be7f-db8a5bc0b26f2026-04-20Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
ZEPATIERELBASVIR AND GRAZOPREVIRMerck Sharp & Dohme LLC164dc02a-9180-426a-b8b5-04ab39d2bbd42026-03-13Boxed warning, Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
BRIDIONSUGAMMADEXMerck Sharp & Dohme LLC5171d883-fe8f-482c-97ab-40b00975b64a2026-03-13Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
SIVEXTROTEDIZOLID PHOSPHATEMerck Sharp & Dohme LLC75672079-589f-451a-bdbf-eaebcfcc80a92026-02-27Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
EMENDFOSAPREPITANT DIMEGLUMINEMerck Sharp & Dohme LLC8d66803a-6811-4c29-9c57-e16acfa87f212026-02-20Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
TICE BCGBACILLUS CALMETTE-GUERINMerck Sharp & Dohme LLCc9b74876-e665-442b-87ad-b7333bc9a67a2026-02-20Boxed warning, Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
TEMODARTEMOZOLOMIDEMerck Sharp & Dohme LLC046a9011-3911-4d3f-a15f-fbb56d5aad562026-02-20Warnings, Adverse reactionsName fallback
manufacturer name: Merck Sharp & Dohme LLC
NOXAFILPOSACONAZOLEMerck Sharp & Dohme LLCb073b082-7b57-4423-8c06-4fd4263d6f842026-02-13Warnings, 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.