FDA.reportPublic FDA data

NDC 58160-815-01 - TWINRIX

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
58160-815
Requested NDC
58160-815-01
Package NDCs from labels
58160-815-43, 58160-815-52, 58160-815-01
Manufacturer
GlaxoSmithKline Biologicals SA
Effective date
2026-05-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TWINRIX - GlaxoSmithKline Biologicals SAGlaxoSmithKline Biologicals SA2026-05-14VACCINE LABEL
TWINRIX - A-S Medication SolutionsA-S Medication Solutions2023-12-09VACCINE LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-03-03Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58160-815-522024-01-30C16284748780-11030e365-137a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TWINRIX safely and effectively. See full prescribing information for TWINRIX. TWINRIX [Hepatitis A & Hepatitis B (Recombinant) Vaccine] injectable suspension, for intramuscular use Initial U.S. Approval: 2001
58160-815-522024-01-30C16284748780-11030e365-137a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TWINRIX safely and effectively. See full prescribing information for TWINRIX. TWINRIX [Hepatitis A & Hepatitis B (Recombinant) Vaccine] injectable suspension, for intramuscular use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58160-815-43TWINRIX1 mL in 1 SYRINGEINJECTION, SUSPENSION134
58160-815-52TWINRIX10 in 1 CARTONINJECTION, SUSPENSION1034

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58160-815TWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]31Current NDC, Legacy NDC, 2 package rows20250426_18e8f9fc-4d62-4d30-4ab7-bac03336171e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58160-815-01ML - Milliliter58160-81579a62666-e61f-4634-bb9d-391a857ac92912013-03-03
58160-815-05ML - Milliliter58160-8153c471fe2-8626-49b2-aae2-df149827240512016-01-13
58160-815-11ML - Milliliter58160-815d3547a57-b73b-4bf3-86cd-e9ce7ab5c05e12013-02-13
58160-815-32ML - Milliliter58160-815ab485cc7-d968-4b1a-a574-90c6e747884d12013-03-03
58160-815-34ML - Milliliter58160-815e6a16786-5348-4fec-bbbd-af112333be9a12016-01-13
58160-815-43ML - Milliliter58160-81514301346-3bcd-4a08-aa21-dc0193c71ba612013-03-03
58160-815-52ML - Milliliter58160-815eaa2da79-0201-432c-b977-758ec7f11d1312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENT5BFC8LZ6LQTWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]17
HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGENACTIVE INGREDIENT9GCJ1L5D1PTWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]17
HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETY5BFC8LZ6LQTWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]17
HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGENACTIVE MOIETY9GCJ1L5D1PTWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]17
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0TWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]17
ALUMINUM PHOSPHATEINACTIVE INGREDIENTF92V3S521OTWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]17
FORMALDEHYDEINACTIVE INGREDIENT1HG84L3525TWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]17
NEOMYCIN SULFATEINACTIVE INGREDIENT057Y626693TWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]17
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHTWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]17
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XTWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]17
WATERINACTIVE INGREDIENT059QF0KO0RTWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]17

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 5 of 75 · 1,499 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neomycin SulfateNEOMYCIN SULFATEShaanxi Shuvita Biotech Co., Ltd573e1fe7-4d9d-0a5f-e063-6394a90a85a82026-07-22WarningsExact identifier
unii: 057Y626693
DERMFREE Triple AntibioticTRIPLE ANTIBIOTICJiangxi Yudexi Pharmaceutical Co., LTD4a5a5603-3478-5f7a-e063-6294a90acc402026-07-21WarningsExact identifier
unii: 057Y626693
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Whisidom Saline SolutionSODIUM CHLORIDE 0.9% SALINE SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4e4e4169-2a14-3466-e063-6394a90a081b2026-07-20WarningsExact identifier
unii: 451W47IQ8X
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
unii: 451W47IQ8X
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONESportpharm LLC9117d5f7-9020-4e76-9bd0-a690b6dfebd32026-07-17Warnings, Adverse reactionsExact identifier
unii: 057Y626693
Gelfos-MALUMINUM PHOSPHATE, COLLOIDAL, MAGNESIUM HYDROXIDE, SIMETHICONEMasaem Company56b9a769-08fb-738f-e063-6294a90a9eb22026-07-16WarningsExact identifier
unii: F92V3S521O
Sodium ChlorideSODIUM CHLORIDELABORATORIOS GRIFOLS SAeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf2026-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
CareALL Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENew World Imports, Inc561bf89c-ca78-d7e4-e063-6394a90a983f2026-07-14WarningsExact identifier
unii: 057Y626693
GOOD NEIGHBOR PHARMACY Antacid Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEAmerisource Bergen5e346dc0-69ce-4cc5-bb5d-bfa833e11c1f2026-07-13WarningsExact identifier
unii: 5QB0T2IUN0
WHWSWB 0.9% SALINESODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd5082b773-79b2-2501-e063-6394a90a170f2026-07-11WarningsExact identifier
unii: 451W47IQ8X
Good Sense First Aid AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BL. Perrigo Company3eadd35c-3df2-4e46-b76d-a6e5378959172026-07-10WarningsExact identifier
unii: 057Y626693
Drs pharmacy triple antibiotic Pain plus itch plus ScarBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENTOL PHARMA TECH, LLC16273878-2f58-0d26-e063-6394a90a47d22026-07-09WarningsExact identifier
unii: 057Y626693
Drs. Pharmacy Triple Antibiotic Plus Pain reliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINEOL PHARMA TECH, LLC Drs PHARMACY1626fa89-cec0-6467-e063-6294a90aa2a42026-07-09WarningsExact identifier
unii: 057Y626693
CareALL Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLNew World Imports, Inc561c1e51-19f4-90ce-e063-6294a90a5f9b2026-07-08WarningsExact identifier
unii: 057Y626693
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
unii: 451W47IQ8X
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Ever Ready First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEEVER READY FIRST AIDee1ad6d7-e9c1-2b20-e053-2995a90a33662026-07-03WarningsExact identifier
unii: 057Y626693
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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