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 35 of 66 · 1,305 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AM-14SILVER, CALCIUM IODIDE, LYTTA VESICATORIA, COPPER, FERROUS IODIDE, GOLDENSEAL, IODINE, DAPHNE MEZEREUM BARK, PHOSPHORIC ACID, PHOSPHORUS, TOXICODENDRON PUBESCENS LEAF, AND RUMEX CRISPUS WHOLEDNA Labs, Inc.8bf2fde6-fd71-47f8-b5ec-c5e34857ab642025-01-09WarningsExact identifier
unii: E4GA8884NN
N-13CEANOTHUS AMERICANUS LEAF, URTICA URENS, SODIUM CHLORIDE, LACHESIS MUTA WHOLE, CINCHONA OFFICINALIS BARK, LYCOPODIUM CLAVATUM WHOLE, FERRIC CHLORIDE HEXAHYDRATE, AND SUS SCROFA SPLEENDNA Labs, Inc.146c5465-bcd9-4057-8975-dc1088b9971b2025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-11CINCHONA OFFICINALIS BARK, PHOSPHORIC ACID, ANEMONE PULSATILLA, PHOSPHORUS, PICRIC ACID, DIBASIC POTASSIUM PHOSPHATE, BOS TAURUS PITUITARY GLAND, POSTERIOR, BOS TAURUS ADRENAL GLAND, SUS SCROFA TESTICLE, AND BOS TAURUS PROSTATE GLANDDNA Labs, Inc.74b694d7-448d-4509-8bc5-fb1eadca9b252025-01-09WarningsExact identifier
unii: E4GA8884NN
N-12PHOSPHORIC ACID, CINCHONA OFFICINALIS BARK, ANEMONE PULSATILLA, PHOSPHORUS, PICRIC ACID, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, VIBURNUM OPULUS WHOLE, BOS TAURUS PITUITARY GLAND, POSTERIOR, BOS TAURUS OVARY, BOS TAURUS ADRENAL GLAND, AND THYROID, UNSPECIFIEDDNA Labs, Inc.89ed00b4-5739-439e-bae9-e00b0b0d72222025-01-09WarningsExact identifier
unii: E4GA8884NN
N-10SODIUM CHLORIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, SEPIA OFFICINALIS JUICE, IODINE, LYCOPODIUM CLAVATUM WHOLE, AND BOS TAURUS PITUITARY GLAND, POSTERIORDNA Labs, Inc.264d8093-70f3-43a5-bfc4-b719bb3e45e62025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-16MGO ENERGIZERDNA Labs, Inc.8292b900-86c1-47ea-81da-b587439c76642025-01-09WarningsExact identifier
unii: 451W47IQ8X
unii: 70WT22SF4B
N-21CALCIUM FLUORIDE, SILICON DIOXIDE, EUPHRASIA STRICTA, RUTA GRAVEOLENS WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, PHYSOSTIGMA VENENOSUM WHOLE, ANEMONE PULSATILLA, SODIUM CHLORIDE, AND SUS SCROFA EYEDNA Labs, Inc.89967941-c4ee-4598-a66d-8a93d69a4d652025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-14FUCUS VESICULOSUS, SODIUM CHLORIDE, LYCOPUS VIRGINICUS, SPONGIA OFFICINALIS SKELETON, ROASTED, POTASSIUM IODIDE, CALCIUM IODIDE, THYROID, UNSPECIFIED, BOS TAURUS ADRENAL GLAND, BOS TAURUS PITUITARY GLAND, POSTERIOR, BOS TAURUS THYMUS, AND SUS SCROFA SPLEENDNA Labs, Inc.3d64739c-5d61-4e88-8612-d5f6994f1c3c2025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-24METABOLINDNA Labs, Inc.559fca2b-1093-4bdf-be70-c453f87002c32025-01-09WarningsExact identifier
unii: 451W47IQ8X
unii: 70WT22SF4B
N-26BARIUM CHLORIDE DIHYDRATE, CONIUM MACULATUM WHOLE, ARNICA MONTANA, PHOSPHORIC ACID, DIBASIC POTASSIUM PHOSPHATE, FERROSOFERRIC PHOSPHATE, AND PORK BRAINDNA Labs, Inc.3fb35088-9c43-411f-992f-43b88ff239152025-01-09WarningsExact identifier
unii: E4GA8884NN
N-27ARNICA MONTANA, MILK THISTLE, SUS SCROFA CEREBRUM, CINCHONA OFFICINALIS BARK, GINKGO BILOBA WHOLE, LECITHIN, SOYBEAN, LITHIUM CARBONATE, ACHILLEA MILLEFOLIUM, PHOSPHORIC ACID, PORK BRAIN, ALNUS GLUTINOSA WHOLE, AND ROSMARINUS OFFICINALIS FLOWERING TOPDNA Labs, Inc.df2d7683-3b45-4ddb-9b67-7bb74dad28542025-01-09WarningsExact identifier
unii: E4GA8884NN
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst8dfb05c0-77e8-2fa1-e053-2a95a90a3d332025-01-08Adverse reactionsExact identifier
unii: 451W47IQ8X
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst998a2a47-5c79-2efd-e053-2995a90a8fac2025-01-08Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst7da788fc-3481-527f-e053-2a91aa0af6ac2025-01-08Adverse reactionsExact identifier
unii: 451W47IQ8X
URIMAR-T CAPSMETHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATEAllegis Pharmaceuticals, LLCcf7c3d65-11d2-49cd-b207-8ccc6a221fe02025-01-08Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
Emetrol Children Mixed BerryPHOSPHORATED CARBOHYDRATEWellSpring Pharmaceutical Corporationecff699b-d4d8-4407-8119-3e9a1100024a2025-01-08WarningsExact identifier
unii: E4GA8884NN

Reported adverse events (FAERS/openFDA)#

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