FDA.reportPublic FDA data

NDC 58160-815-11 - 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
58160-815-11
Package NDCs from labels
58160-815-43, 58160-815-52, 58160-815-11
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 Programs2013-02-13Indexing - 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 1 of 77 · 1,521 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: 451W47IQ8X
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATENuCare Pharmaceutical, Inc.5b14499e-e45c-7c05-e063-6294a90a1cc22026-09-09WarningsExact identifier
unii: 057Y626693
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
unii: 451W47IQ8X
ClaravieALUMINUM HYDROXIDE GELGentell LLC5afea757-8feb-f907-e063-6394a90a62592026-09-08WarningsExact identifier
unii: 5QB0T2IUN0
Thyroid SupportCALCAREA CARBONICA, CALCAREA IODATA, CAUSTICUM, FERRUM IODATUM, FUCUS VESICULOSUS, KALI IODATUM, NATRUM MURIATICUM, THYROIDINUM (BOVINE)NaturalCare07b4e0ed-2b00-4d0a-ad8f-fc6deff153252026-09-08WarningsExact identifier
unii: 451W47IQ8X
American Safety and First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Inceb0df2da-1688-c477-e053-2995a90a74a22026-09-07WarningsExact identifier
unii: 057Y626693
American Safety and First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Inceb0d108f-42bf-3364-e053-2a95a90a45422026-09-07WarningsExact identifier
unii: 057Y626693
MEDI-FIRSTBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incf4e4d0a4-b90c-99b0-e053-2995a90ab4232026-09-04WarningsExact identifier
unii: 057Y626693
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: 451W47IQ8X
Lil Drug Store Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEORAZEN INCe6e5263b-328f-4775-9fac-34302f050ce02026-09-04WarningsExact identifier
unii: 057Y626693
MEDI-FIRSTBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incf4e42c5c-e080-4efb-e053-2a95a90af52e2026-09-04WarningsExact identifier
unii: 057Y626693
MEDI-FIRSTBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incf4e4854a-ee01-df72-e053-2995a90aa8ea2026-09-04WarningsExact identifier
unii: 057Y626693
Circle K Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEORAZEN INC84c3f7e4-b28b-40bb-8d9d-7c8d679e3a3a2026-09-04WarningsExact identifier
unii: 057Y626693
First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLWalgreen Companyb982091a-5aa0-4bbc-bb1d-08016f6d0a702026-09-03WarningsExact identifier
unii: 057Y626693
KROGER SalineNASALKROGER COMPANYc84b242b-f46e-4ea8-a3c1-109a476446462026-09-02WarningsExact identifier
unii: 451W47IQ8X
SurviveX Triple AntibioticTRIPLE ANTIBIOTICNantong Health & Beyond Hygienic Products Inc.5a7cb52d-a60c-b947-e063-6394a90afb0d2026-09-02WarningsExact identifier
unii: 057Y626693
Adrenal SupportADRENALINUM, ARGENTUM NITRICUM, BERBERIS VULGARIS, NATRUM MURIATICUM, OLEUM MORRHUAE, PETROLEUM, VANADIUMNaturalCare31a5d522-15cd-432a-bf87-f721bcbe2e312026-09-02WarningsExact identifier
unii: 451W47IQ8X
Xtreme Saline Rinse MixSODIUM BICARBONATE, SODIUM CHLORIDEXtreme Personal Care Inc776f417e-e443-4918-8c7a-1913b7dddcd42026-09-01WarningsExact identifier
unii: 451W47IQ8X
Kroger Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATETHE KROGER CO.,175d9f0f-266a-4dc2-865f-d1ebd4ddac512026-09-01WarningsExact identifier
unii: 5QB0T2IUN0
Nacl 0.9% Normal Saline SolutionSODIUM CHLORIDECHI FUNG TECHNOLOGY COMPANY5a53c4c8-c9de-700c-e063-6394a90a3ab52026-08-31WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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