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 61 of 65 · 1,281 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Connec-TECHINACEA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BERBERIS AQUIFOLIUM, CALCAREA FLUORICA, CAPSICUM ANNUUM, CARDUUS MARIANUS, CINCHONA OFFICINALIS, IODIUM, KALI CARBONICUM, LACHESIS MUTUS, MAGNESIA CARBONICA, MERCURIUS VIVUS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORUS, PHYTOLACCA DECANDRA, SECALE CORNUTUM, THYMUS SERPYLLUM, THUJA OCCIDENTALIS, THYROIDINUM, VERBASCUM THAPSUS.Newton Laboratories, Inc.9a630923-1497-1fc8-e053-2995a90ad0012020-12-02WarningsExact identifier
unii: 451W47IQ8X
Distress-Mood-SadnessANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGONewton Laboratories, Inc.98d0be75-9b50-1e15-e053-2995a90abf3b2020-12-02WarningsExact identifier
unii: 451W47IQ8X
Distress-Mood-SadnessANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGONewton Laboratories, Inc.98d08917-2f1b-4dc7-e053-2a95a90a1ce02020-12-02WarningsExact identifier
unii: 451W47IQ8X
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9aefc830-329c-5e35-e053-2a95a90a6ffe2020-11-30WarningsExact identifier
unii: 451W47IQ8X
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9af2d6f4-baa8-5da9-e053-2995a90a3dac2020-11-30WarningsExact identifier
unii: 451W47IQ8X
Hair-ScalpAPIS MEL., ARSENICUM ALB., CALC. CARB., DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDRASTIS, HYDROFLUORICUM ACIDUM, KALI CARB., LYCOPODIUM, MEZEREUM, OLEANDER, PETROLEUM, PHOSPHORICUM AC., PHOSPHORUS, RHUS TOXICODENDRON, SELENIUM, SEPIA, SILICEA, SULPHUR, THUJA OCC.Newton Laboratories, Inc.9ab3b944-443c-74a1-e053-2a95a90aa0e52020-11-30WarningsExact identifier
unii: E4GA8884NN
Fatigue FighterACONITUM NAP., ADRENALINUM, ARALIA QUINQUEFOLIA, ARNICA, ARSENICUM ALB., BAPTISIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CINCHONA, IODIUM, KALI CARB., KALI IOD., LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, NAT. MUR., NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABAL, THYROIDINUM, ECHINACEA, GINGKO, PHYTOLACCA.Newton Laboratories, Inc.9aa3c692-fbe0-debe-e053-2995a90add502020-11-25WarningsExact identifier
unii: 451W47IQ8X
Fatigue FighterACONITUM NAP., ADRENALINUM, ARALIA QUINQUEFOLIA, ARNICA, ARSENICUM ALB., BAPTISIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CINCHONA, IODIUM, KALI CARB., KALI IOD., LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, NAT. MUR., NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABAL, THYROIDINUM, ECHINACEA, GINGKO, PHYTOLACCA.Newton Laboratories, Inc.9ab1c9ba-a90e-7f55-e053-2a95a90a94512020-11-25WarningsExact identifier
unii: 451W47IQ8X
Feminine ComfortAGARICUS MUSC., ARSENICUM ALB., AUR. MET., BERBER. AQUI., CALADIUM SEGUINUM, CANDIDA ALBICANS, CANTHARIS, CONIUM, GRAPHITES, HELONIAS DIOICA, HYDRASTIS, KALI CARB., KREOSOTUM, LYCOPODIUM, MERC. VIV., MUREX PURPUREA, NAT. MUR., NITRICUM AC., PULSATILLA, RHUS TOXICODENDRON, SEPIA, SULPHUR, TARENTULA HISPANA, THUJA OCC., ZINC. MET., APIS MEL., HAMAMELISNewton Laboratories, Inc.9ab4520d-1dd3-7b9f-e053-2a95a90a274f2020-11-25WarningsExact identifier
unii: 451W47IQ8X
Blues - Mood - EmotionsANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGONewton Laboratories, Inc.79890e75-dfac-0262-e053-2a91aa0a5ce52020-11-24WarningsExact identifier
unii: 451W47IQ8X
Blues - Mood - EmotionsANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGONewton Laboratories, Inc.798ab5a2-7464-8e9d-e053-2a91aa0acc982020-11-24WarningsExact identifier
unii: 451W47IQ8X
Cold Hands - FeetHISTAMINUM HYDROCHLORICUM,THYROIDINUM, ACONITUM NAP., ARSENICUM ALB., BRYONIA, CACTUS, CALC. FLUOR., CEANOTHUS, CINCHONA, CONVALLARIA, DIGITALIS, GELSEMIUM, GLONOINUM, HYDROCOYLE, KALI CARB., LACHESIS, NAJA, NAT CARB., NAT MUR., NUX VOM., PHOSPHORUS, PULLSATILLA, RHUS TOXICODENDRON, STROPHANTHUS HISPIDUS, SULPHUR, ECHINACEANewton Laboratories, Inc.7a2b4f28-2128-a8b2-e053-2a91aa0a24022020-11-24WarningsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEAsclemed USA, Inc.afac6cc5-1ced-4639-b6f6-86f40ef5c30e2020-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GUNA ALLERGYADRENALINUM - ALLIUM CEPA - AMMONIUM CARBONICUM - APIS MELLIFICA - ARGENTUM NITRICUM - ARSENICUM ALBUM - CUPRUM ACETICUM - GALPHIMIA GLAUCA - GLANDULA SUPRARENALIS SUIS - HISTAMINUM HYDROCHLORICUM - LUFFA OPERCULATA - MATRICARIA CHAMOMILLA - MUCOSA NASALIS SUIS - NATRUM MURIATICUM - SABADILLA - SCILLA MARITIMA -Guna spaae6bd80d-2c70-1a3f-e053-2a95a90a26522020-10-23WarningsExact identifier
unii: 451W47IQ8X
InterSolPLATELET ADDITIVE 3Fenwal, Inc.a00c4a93-cde2-4753-81f7-0d6fee9fb6902020-10-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: 593YOG76RN
SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstac0fd44a-3f39-8d7e-e053-2995a90afeec2020-08-04Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
CardioplegicCALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM CHLORIDEBaxter Healthcare Corporation1fd50ce5-2799-4c26-81da-02cf0578dd9e2020-06-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.ee831456-5962-4d5e-ad0c-69ab858604532020-06-03Exact identifier
unii: 593YOG76RN
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta62b71db-8ba2-6f6b-e053-2a95a90a29d12020-05-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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