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
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 8 of 73 · 1,448 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Careland Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEPlanet (Anhui) Pharmaceutical Co., Ltd.0e64179d-fce2-48fc-833e-ce43a54b987c2026-05-31WarningsExact identifier
unii: 057Y626693
First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHubei Fanjian Medical Product Co.,Ltdf44ab989-c618-1831-e053-2995a90adc8e2026-05-28WarningsExact identifier
unii: 057Y626693
REGULAR STRENGTH ANTACID/ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONENuCare Pharmaceuticals, Inc.52e75fe4-f04f-31da-e063-6294a90a1e4f2026-05-28WarningsExact identifier
unii: 5QB0T2IUN0
PlegisolPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDEHospira, Inc.35a174f0-f0d7-4ec7-3f81-d3d572c059cf2026-05-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
TPN ElectrolytesSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND SODIUM ACETATE ANHYDROUSHospira, Inc.c00817bc-7b62-4abe-0280-e7930eda3f942026-05-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SALINE CLEANINGSODIUM CHLORIDEGuangzhou Huanmei Cosmetics Co., Ltd.524f07cc-ddb9-dda5-e063-6394a90ac0a52026-05-21WarningsExact identifier
unii: 451W47IQ8X
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
TRIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHART Health3d17aba0-220f-42c4-9e26-5c44857847cd2026-05-20Warnings, Adverse reactionsExact identifier
unii: 057Y626693
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.a2a964f7-c3ec-4dfb-e3a0-6d8136a803972026-05-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLCe5e7aa2f-3697-4747-9045-670ea2b135572026-05-14WarningsExact identifier
unii: 451W47IQ8X
triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWalgreens Co.32df5cca-77bc-45d2-b1f6-2cfdfc371ea92026-05-12WarningsExact identifier
unii: 057Y626693
ANTIBIOTIC Maximum StrengthBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWalgreens Co.653c88bf-5b7d-45be-a131-d59990573e9c2026-05-12WarningsExact identifier
unii: 057Y626693
NebuClear MDSALINEBlue Echo Care LLC3f85fe62-230f-b0f1-e063-6394a90a5cb82026-05-11WarningsExact identifier
unii: 451W47IQ8X
Kesin MAG-AL PlusALUMINUM AND MAGNESIUM HYDROXIDE W/SIMETHICONE SUSPENSIONKesin Pharma Corporation436b622a-f028-df98-e063-6394a90a3eaa2026-05-08WarningsExact identifier
unii: 5QB0T2IUN0
Kesin MAG-AL Plus XSALUMINUM AND MAGNESIUM HYDROXIDE W/SIMETHICONE SUSPENSIONKesin Pharma Corporation436b89f7-e417-0df2-e063-6394a90a96df2026-05-08WarningsExact identifier
unii: 5QB0T2IUN0
Kesin MAG-ALALUMINUM AND MAGNESIUM HYDROXIDE SUSPENSIONKesin Pharma Corporation42df2198-14dc-da1c-e063-6394a90a1ae62026-05-08WarningsExact identifier
unii: 5QB0T2IUN0
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: 451W47IQ8X
Migraine ReliefBELLADONNA, BRYONIA (ALBA), CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, GLONOINUM, IRIS VERSICOLOR, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISThe Magni Company79b25c52-e145-4ee5-af2e-1ccf6ad5ac2d2026-05-07WarningsExact identifier
unii: 451W47IQ8X
Harris Teeter Triple Antibiotic and Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC, PRAMOXINE HCLHARRIS TEETER LLC4b0c0a3c-7145-97ca-e063-6394a90a1a962026-05-07WarningsExact identifier
unii: 057Y626693

Reported adverse events (FAERS/openFDA)#

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