FDA.reportPublic FDA data

NDC 58468-0348-01 - Qfitlia

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
58468-0348
Requested NDC
58468-0348-01
Package NDCs from labels
58468-0348-1, 58468-0348-01
Manufacturer
Genzyme Corporation | Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse) | Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Helmut-Vetter-Strasse) | PPD Development Ireland Ltd. | Sanofi-Aventis Deutschland GmbH | BioSpring GmbH | Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) | Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)
Effective date
2025-09-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
QfitliaGenzyme Corporation | Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse) | Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Helmut-Vetter-Strasse) | PPD Development Ireland Ltd. | Sanofi-Aventis Deutschland GmbH | BioSpring GmbH | Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) | Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)2025-09-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58468-0348-1Qfitlia0.5 mL in 1 SYRINGEINJECTION, SOLUTION0.56
58468-0348-1Qfitlia1 in 1 CARTONINJECTION, SOLUTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58468-0348QFITLIA (FITUSIRAN) INJECTION, SOLUTION [GENZYME CORPORATION]3Current NDC, 2 package rows20250331_6dd2f8ac-6f90-4cbf-b197-97d74964135c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58468-0348-1ML - Milliliter58468-03487352a545-7376-4698-9d88-2901a668a53c12025-05-14

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 48 of 66 · 1,305 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye WashWATERJiangxi Zhenmei Biological Technology Co.,Ltdc68795b8-bf68-0d01-e053-2a95a90abebb2023-12-04WarningsExact identifier
unii: 059QF0KO0R
terrasil Eczema and Psoriasis Severe OutbreakGRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIGAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions4d7128fb-57f1-4d0d-a83a-daef40928ecd2023-11-30WarningsExact identifier
unii: 451W47IQ8X
terragen HG Formula Maximum StrengthGRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIGAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionse632c831-e25d-4d04-ba72-2327d25713b12023-11-30WarningsExact identifier
unii: 451W47IQ8X
Femstat CECHINACEA (ANGUSTIFOLIA), FUCUS VESICULOSUS, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, KREOSOTUM, NATRUM MURIATICUM, CANDIDA ALBICANS, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), SEPIAEnergique, Inc.420119ca-f2bf-40e3-9e40-00498724c2282023-11-30WarningsExact identifier
unii: 451W47IQ8X
EndoparGLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, OOPHORINUM (SUIS), ORCHITINUM (BOVINE), PINEAL GLAND, THYROIDINUM, ARSENICUM ALBUM, BARYTA CARBONICA, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PULSATILLA (PRATENSIS)Energique, Inc.06375c3e-cc05-4450-9117-1d3dc72636eb2023-11-21WarningsExact identifier
unii: 451W47IQ8X
unii: E4GA8884NN
TerrestristatALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), CEREBRUM SUIS, PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, COFFEA CRUDA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, RADIUM BROMATUM, CARCINOSIN, TARENTULA CUBENSIS, X-RAY, HOLMIUM METALLICUM, URANIUM NITRICUM.Energique, Inc.9bd83312-6872-4e39-b7ff-bbeb69015d802023-11-17WarningsExact identifier
unii: E4GA8884NN
Natrum muriaticumSODIUM CHLORIDEBoiron8646d7ea-cf5e-607d-e053-2a91aa0aeca12023-11-14Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86466121-7217-d053-e053-2a91aa0a8f8a2023-11-14Exact identifier
unii: 451W47IQ8X
Natrum phosphoricumSODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEBoiron86471181-da77-f4ad-e053-2991aa0a15552023-11-14Exact identifier
unii: 70WT22SF4B
Natrum muriaticumSODIUM CHLORIDEBoiron864669c9-5bdc-232f-e053-2a91aa0a1fc62023-11-14Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86462e06-d221-36b7-e053-2991aa0a1d822023-11-14Exact identifier
unii: 451W47IQ8X
Natrum phosphoricumSODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEBoiron86472dc7-5d6a-c3bc-e053-2a91aa0a0e632023-11-14Exact identifier
unii: 70WT22SF4B
Phosphoricum acidumPHOSPHORIC ACIDBoiron869341a5-be11-4351-e053-2a91aa0a5eec2023-11-14Exact identifier
unii: E4GA8884NN
Phosphoricum acidumPHOSPHORIC ACIDBoironae0094e0-7bf0-11e6-8451-424c583030312023-11-14Exact identifier
unii: E4GA8884NN
Phosphoricum acidumPHOSPHORIC ACIDBoiron8693b9fd-b02f-84aa-e053-2a91aa0a00292023-11-14Exact identifier
unii: E4GA8884NN
Phosphoricum acidumPHOSPHORIC ACIDBoiron8693b9fd-b048-84aa-e053-2a91aa0a00292023-11-14Exact identifier
unii: E4GA8884NN
Phosphoricum acidumPHOSPHORIC ACIDBoiron86937d85-7ffc-0992-e053-2a91aa0a7d0a2023-11-14Exact identifier
unii: E4GA8884NN
Phosphoricum acidumPHOSPHORIC ACIDBoiron8693180c-3b5b-27eb-e053-2a91aa0a18e22023-11-13Exact identifier
unii: E4GA8884NN
CV TOXCOCHLEARIA ARMORACIA, ECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PROPOLIS, GLANDULA SUPRARENALIS BOVINE, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, MORBILLINUM, POLIOMYELITIS NOSODE, HEPATITIS B NOSODE, COXSACKIE B1 NOSODE, CYTOMEGALOVIRUS NOSODE, COXSACKIE B4 NOSODE, EPSTEIN BARR VIRUS NOSODEBioActive Nutritional, Inc.8ef2fb5c-1b24-46a1-8d21-a78ce0a34a872023-11-07WarningsExact identifier
unii: E4GA8884NN
VermistatARTEMISIA VULGARIS, CINA, SABADILLA, SPIGELIA ANTHELMIA, FILIX MAS, BARYTA CARBONICA, CALCAREA CARBONICA, CINCHONA OFFICINALIS, NATRUM PHOSPHORICUM, SULPHUR, TEREBINTHINA, PROTEUS (VULGARIS)Energique, Inc.acb43b1a-52fd-484b-96a8-1cfe97c1f3982023-11-02WarningsExact identifier
unii: 70WT22SF4B

Reported adverse events (FAERS/openFDA)#

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