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 59 of 65 · 1,281 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0.9% SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstc755e41b-acba-7234-e053-2995a90aff0f2021-07-17Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Passiflora PlexPASSIFLORA INCARNATA, IGNATIA AMARA, JALAPA, COFFEA CRUDA, MAGNESIUM METALICUM, PALLADIUM METALLICUM, TELLURIUM METALLICUM, PHOSPHORICUM ACIDUMSeroyal USA0eabdf34-4d4c-3282-e054-00144ff8d46c2021-07-15WarningsExact identifier
unii: E4GA8884NN
Melange combinationCALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEASeroyal USA0a071fbf-0075-4479-e054-00144ff8d46c2021-07-14WarningsExact identifier
unii: 451W47IQ8X
unii: 70WT22SF4B
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC4a655cde-283f-4ec8-a3d9-5f539c55c2042021-05-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCed8fd0c1-ac42-4267-877e-ceadf3831c902021-04-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dr. Talbots Vital 12CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA, ZINC GLUCTalbot's Pharmaceuticals Family Products, LLCc10bb804-8169-63da-e053-2a95a90a83062021-04-28WarningsExact identifier
unii: 451W47IQ8X
unii: 70WT22SF4B
Dr. Talbots Infant Daily Allergy ReliefALLIUM CEPA, ARALIA RACEMOSA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, LUFFA OPERCULATA, PULSATILLA, SOLIDAGO, NATRUM MURIATICUMTalbot's Pharmaceuticals Family Products, LLCc0963200-67dd-6349-e053-2a95a90adde12021-04-22WarningsExact identifier
unii: 451W47IQ8X
CLINIMIX ELEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSEBaxter Healthcare Company8469d6fb-d6ef-476f-8cc3-0905192de0a82021-04-13Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEMedical Purchasing Solutions, LLCc3f8e83c-4fb9-91da-e053-2a95a90abd632021-04-12Adverse reactionsExact identifier
unii: 451W47IQ8X
CVS Health Sterile Saline Mist Live BetterSODIUM CHLORIDECVS Pharmacyccc3ab8c-b22f-420d-869b-f2a65b8c71802021-03-13WarningsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporationaeaed9cb-b629-4019-88d2-a916179427de2021-02-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GUNA KIDNEY PLUSCALCIUM SULFIDE - CHONDRODENDRON TOMENTOSUM ROOT - EQUISETUM HYEMALE - SUS SCROFA PITUITARY GLAND - APIS MELLIFERA - URTICA URENS - SODIUM CHLORIDE - LOBARIA PULMONARIA - HORSE CHESTNUT - BERBERIS VULGARIS FRUIT - SOLIDAGO VIRAGAUREA FLOWERING TOP -Guna spab8dacd94-8da1-4a8d-e053-2995a90acb672021-02-04WarningsExact identifier
unii: 451W47IQ8X
Candid- YADRENALINUM, CANDIDA ALBICANS, THYROIDINUM, TORULA CEREVISIAE, TRITICUM, USTILAGO MAIDIS, ANTIMON. CRUD, ARSENICUM ALB., BAPTISIA, BERBER. AQUI., BRYONIA, CALC. PHOS., CINCHONA, HELONIAS DIOICA, HYDRASTIS, IODIUM, IRIS VERSICOLOR, KALI CARB., LACHESIS, LYCOPODIUM, MERC. VIV., NAT.CARB., NAT. PHOS, NITRICUM AC., PHOSPHORUS, PODOPH. PELT, PULSATILLA, SEPIA, ECHINACEA, GINKGO, JUGLANS REGIA, LAPPA, THUJA OCC.Newton Laboratories, Inc.c68c9c20-3a07-16df-e053-2a95a90a0cbc2021-02-01WarningsExact identifier
unii: 70WT22SF4B
Candid-YADRENALINUM, CANDIDA ALBICANS, THYROIDINUM, TORULA CEREVISIAE, TRITICUM, USTILAGO MAIDIS, ANTIMON. CRUD, ARSENICUM ALB., BAPTISIA, BERBER. AQUI., BRYONIA, CALC. PHOS., CINCHONA, HELONIAS DIOICA, HYDRASTIS, IODIUM, IRIS VERSICOLOR, KALI CARB., LACHESIS, LYCOPODIUM, MERC. VIV., NAT.CARB., NAT. PHOS, NITRICUM AC., PHOSPHORUS, PODOPH. PELT, PULSATILLA, SEPIA, ECHINACEA, GINKGO, JUGLANS REGIA, LAPPA, THUJA OCC.Newton Laboratories, Inc.c68ea9c3-f95c-dbcd-e053-2995a90a9aeb2021-02-01WarningsExact identifier
unii: 70WT22SF4B
Candid-YADRENALINUM, CANDIDA ALBICANS, THYROIDINUM, TORULA CEREVISIAE, TRITICUM, USTILAGO MAIDIS, ANTIMON. CRUD, ARSENICUM ALB., BAPTISIA, BERBER. AQUI., BRYONIA, CALC. PHOS., CINCHONA, HELONIAS DIOICA, HYDRASTIS, IODIUM, IRIS VERSICOLOR, KALI CARB., LACHESIS, LYCOPODIUM, MERC. VIV., NAT.CARB., NAT. PHOS, NITRICUM AC., PHOSPHORUS, PODOPH. PELT, PULSATILLA, SEPIA, ECHINACEA, GINKGO, JUGLANS REGIA, LAPPA, THUJA OCC.Newton Laboratories, Inc.c6a37dbe-3092-5ecf-e053-2a95a90a7c392021-02-01WarningsExact identifier
unii: 70WT22SF4B
Natrum MuriaticumNATRUM MURIATICUMTrue Botanica, LLCb30b2880-28a1-47bd-83e7-da885a7c6f772021-01-24WarningsExact identifier
unii: 451W47IQ8X
Met-ToxARSENICUM ALBUM, AVENA SATIVA,LYCOPODIUM CLAVATUM,NATRUM MURIATICUM,NUX VOMICA,PHYTOLACCA DECANDRARHAMNUS FRANGULA,SOLIDAGO VIRGAUREA,TRIFOLIUM PRATENSE,HEAVY METAL NOSODESwHITE mANUFACTURING INC DBA MICRO-WESTe65db4c2-0bc7-4c50-8f18-b36ee004c4f52021-01-21WarningsExact identifier
unii: 451W47IQ8X
CAND-EXLYCOPODIUM,NUX VOMICA,BORAX,ASAFOETIDA,NUX MOSCHATA,GENTIANA LUTEA,KREOSOTUM,CALCAREA CARBONICA,SEPIA,PHOSPHORIC ACID,ECHINACEA,PULSATILLA,BAPTISIA,WHITE MANUFACTURING INC. DBA MICRO WEST4d650a1d-c6b5-410e-9e59-3753a373cc222021-01-21WarningsExact identifier
unii: E4GA8884NN
HPZECHINACEA, GELSEMIUM, HYDRASTIS, HYPERICUM, LYCOPODIUM, NAT MUR, NITRICUM AC, RANUNC BULB, RHUS TOX, THUJA OCCWhite Manufacturing Inc. DBA Micro-Westdfbb5a35-8dfe-48f4-9177-6cb52fb440902021-01-21WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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