FDA.reportPublic FDA data

NDC 58160-855-01 - Arepanrix

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
58160-855
Requested NDC
58160-855-01
Package NDCs from labels
58160-855-01, 58160-855-19
Manufacturer
GlaxoSmithKline Biologicals SA
Effective date
2026-04-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Arepanrix - GlaxoSmithKline Biologicals SAGlaxoSmithKline Biologicals SA2026-04-28VACCINE LABEL
AS03 - GlaxoSmithKline Biologicals SAGlaxoSmithKline Biologicals SA2025-12-31VACCINE LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58160-855-192024-02-10C16284748780-11030e365-6622-111a-e063-dadaa90a10e2f136b41b-56f3-43a9-9d6a-61b2afca5b4a
58160-855-192024-01-30C16284748780-11030e365-6622-111a-e063-dadaa90a10e2f136b41b-56f3-43a9-9d6a-61b2afca5b4a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58160-855-01AS032.5 mL in 1 VIALINJECTION, SOLUTION2.53
58160-855-19AS0310 in 1 CARTONINJECTION, SOLUTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58160-855AS03 INJECTION, SOLUTION [GLAXOSMITHKLINE BIOLOGICALS SA]2Current NDC, Legacy NDC, 2 package rows20240210_f136b41b-56f3-43a9-9d6a-61b2afca5b4a.zip

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 63 of 76 · 1,503 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Virility LiquescenceAVENA SATIVA, DAMIANA, BERBERIS VULGARIS, EPIMEDIUM GRANDIFLORUM, GLYCERINUM, SABAL SERRULATA, IODIUM, LECITHIN, FERRUM MURIATICUM, NATRUM MURIATICUM, AGNUS CASTUS, BUFO RANA, CINCHONA OFFICINALIS, HUMAN GROWTH HORMONE (HGH), ORCHITINUM (BOVINE), PHOSPHORICUM ACIDUM, PHOSPHORUS, SELENIUM METALLICUM, ZINCUM VALERIANICUM, OOPHORINUM (SUIS), SEPIANutritional Specialties, Inc.81cc3e2b-f95e-4ba4-a15f-c07b4def0e2f2023-03-29WarningsExact identifier
unii: 451W47IQ8X
Spleen Thymus LiquescenceCINCHONA OFFICINALIS, QUERCUS GLANDIUM SPIRITUS, CEANOTHUS AMERICANUS, SPLEEN (BOVINE), THYMUS (BOVINE), CHININUM ARSENICOSUM, NATRUM MURIATICUM, HELIANTHUS ANNUUSNutritional Specialties, Inc.bc1cc31e-0e8a-49a2-9654-f00eaa72fc042023-03-24WarningsExact identifier
unii: 451W47IQ8X
Myco Immuno NosodeDU HUO (ANGELICA PUBESCENS), ANGELICA ARCHANGELICA, KALI MURIATICUM, RADIX SILERIS (SAPOSHNIKOVIA DIVARICATA), YUCCA FILAMENTOSA, ACHYRANTHES BIDENTATA, ANGELICA SINENSIS, LIGUSTICUM PORTERI, PANAX GINSENG, RHUS TOX, HYDRASTIS CANADENSIS, UNCARIA TOMENTOSA, CARTILAGO SUIS, HORDEUM VULGARE, OXALICUM ACIDUM, ARNICA MONTANA, LATRODECTUS MACTANS, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, BORRELIA BURGDORFERI, BABESIA MICROTINutritional Specialties, Inc.34dc93af-0c39-4e06-a8d6-9e1ccc77aa232023-03-17WarningsExact identifier
unii: 660YQ98I10
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Potassium ChloridePOTASSIUM CHLORIDEFresenius Kabi USA, LLCfcd4f458-ce27-417e-9bb6-de1cc49d44b92023-02-27Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
K-Phos No. 2POTASSIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSBeach Products, Inc.9f446400-c403-4971-879e-1341f7f7d9da2023-02-23Adverse reactionsExact identifier
unii: 4J9FJ0HL51
K Phos OriginalPOTASSIUM PHOSPHATE, MONOBASICBeach Products, Inc.04557ab3-6d21-49b4-b849-744c75b8a6302023-02-23Adverse reactionsExact identifier
unii: 4J9FJ0HL51
K Phos NeutralSODIUM PHOSPHATE, DIBASIC, ANHYDROUS, POTASSIUM PHOSPHATE, MONOBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEBeach Products, Inc.83376725-ee0f-40ad-bd90-31a61b9445cf2023-02-23Adverse reactionsExact identifier
unii: 22ADO53M6F
unii: 4J9FJ0HL51
Natrum muriaticumSODIUM CHLORIDEBoiron1ef4a040-7bee-11e6-8371-424c583030312023-02-20Exact identifier
unii: 451W47IQ8X
Natrum phosphoricumSODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEBoiron12e87e30-7c60-11e6-869d-424c583030312023-02-20Exact identifier
unii: 70WT22SF4B
Natrum muriaticumSODIUM CHLORIDEBoiron8645e304-a71b-5cba-e053-2a91aa0a2d882023-02-20Exact identifier
unii: 451W47IQ8X
EyeClear ProCALC CARB, CALC FLUOR, CAUSTICUM, CINERARIA, EUPHRASIA, NAPHTHALINUM, NAT MUR, PHOS, QUASSIA, SILICEASilver Star Brandsf4d4943b-cb78-aa71-e053-2a95a90ac6382023-02-16WarningsExact identifier
unii: 451W47IQ8X
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTESPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESNovel Laboratories, Inc.29d821ff-389c-41fb-8a27-89bd3f022b822023-02-08Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions87cc7349-5a07-4a39-be97-4e1013814f302023-02-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
POTASSIUM CHLORIDE EXTENDED RELEASEPOTASSIUM CHLORIDEGranules Pharmaceuticals Inc.9f8d2886-9ecd-4cbf-a84a-2d221cb3497c2023-01-27Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Natrum muriaticumSODIUM CHLORIDEBoiron86463b98-58f5-7f65-e053-2a91aa0ad3a22023-01-23Exact identifier
unii: 451W47IQ8X
Kali muriaticumPOTASSIUM CHLORIDEBoiron8608d5a3-93e6-e8e2-e053-2a91aa0aaedc2023-01-23Exact identifier
unii: 660YQ98I10
Natrum muriaticumSODIUM CHLORIDEBoiron8645f130-6a19-ae73-e053-2991aa0ab05b2023-01-23Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8645eb60-65d1-9d6c-e053-2991aa0a94ef2023-01-23Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8644ffef-f0e6-5c06-e053-2a91aa0ae83d2023-01-23Exact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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