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 5 of 69 · 1,377 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fdf83e-f641-1f69-e063-6394a90ab7502026-06-24Exact identifier
unii: 593YOG76RN
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
MCAS SupportAPIS MELLIFICA, ANTIMONIUM CRUDUM, ASCORBICUM ACIDUM, BOVISTA, CARBOLICUM ACIDUM, CHAMOMILLA, CORTISONE ACETICUM, GINKGO BILOBA, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, QUERCETIN, RHUS TOX, SCUTELLARIA LATERIFLORA, STOMACH (SUIS), URTICA URENSDeseret Biologicals, Inc.af3d5f8f-6f24-4045-8730-c776ff54bcc42026-06-24WarningsExact identifier
unii: 451W47IQ8X
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM HAIR SUPPORT DROPSACID PHOS, ARNICA MONT, ARS. ALB., GRAPHITE, JABORANDI, LYCOPODIUM, PHOSPHORUS, SULPHURTotal Operations Management LLC DBA:Bestmade Natural Products Micro5460d96f-e2b1-51ff-e063-6294a90ac7822026-06-16WarningsExact identifier
unii: E4GA8884NN
BM VITAGENE FORTE SOLIDACID PHOS, AGNUS CASTUS, CALADIUM SEG, DAMIANA, GINSENG PANAX, SABAL SERR, SCUTELLARIA LAT, SELENIUM, YOHIMBINUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro54610bfe-87bf-06ed-e063-6394a90ae1cd2026-06-16WarningsExact identifier
unii: E4GA8884NN
0.9% Sodium Chloride Saline SolutionSODIUM CHLORIDEYunqi Cosmetics (Shenzhen) Co., Ltd546af257-dbd1-11fc-e063-6394a90a8e0a2026-06-16WarningsExact identifier
unii: 451W47IQ8X
BM BM68 DROPSARGENTUM NIT, BARYTA CARB., DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUMBM Private Limited53f9c99a-0f20-0358-e063-6394a90af4e02026-06-15WarningsExact identifier
unii: 451W47IQ8X
BM BM68ARGENTUM NIT, BARYTA CARB, DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5448c76a-2ecb-9402-e063-6294a90a6ad72026-06-15WarningsExact identifier
unii: 451W47IQ8X
BM HAIR SUPPORT DROPSACID PHOS, ARNICA MONT, ARS. ALB., GRAPHITE, JABORANDI, LYCOPODIUM, PHOSPHORUS, SULPHURBM Private Limited544b1ad5-71ab-18e4-e063-6394a90a86352026-06-15WarningsExact identifier
unii: E4GA8884NN
BM BIO24 ICING SUGARCALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT PHOSTotal Operations Management LLC DBA:Bestmade Natural Products Micro544b2bf9-74e8-297f-e063-6394a90a3dac2026-06-15WarningsExact identifier
unii: 70WT22SF4B
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: 451W47IQ8X
unii: 70WT22SF4B
BM VITAGENE FORTE DROPSACID PHOS, AGNUS CASTUS, CALADIUM SEG, DAMIANA, GINSENG PANAX, SABAL SERR, SCUTELLARIA LAT, SELENIUM, YOHIMBINUMBM Private Limited544d11cd-3cfa-9c91-e063-6294a90a85262026-06-15WarningsExact identifier
unii: E4GA8884NN
BM VITAGENE FORTE SOLIDACID PHOS, AGNUS CASTUS, CALADIUM SEG, DAMIANA, GINSENG PANAX, SABAL SERR, SCUTELLARIA LAT, SELENIUM, YOHIMBINUMBM Private Limited544e41b1-cfac-ae63-e063-6394a90ac69b2026-06-15WarningsExact identifier
unii: E4GA8884NN
Male SupportAGNUS CASTUS, AURUM METALLICUM, BENZOICUM ACIDUM, BRYONIA (ALBA), BUFO RANA, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, CONIUM MACULATUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, KALI ARSENICOSUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PROSTATE (SUIS), RHODODENDRON CHRYSANTHUM, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, TESTOSTERONE, THUJA OCCIDENTALISDeseret Biologicals, Inc.29cefc89-3bb6-484e-84ab-116b5827a4c32026-06-15WarningsExact identifier
unii: 451W47IQ8X
BM BM213CARBO VEG, GRAPHITES, NAT PHOS, NAT SULPH, RHUS TOXTotal Operations Management LLC DBA:Bestmade Natural Products Micro54396b10-a115-5b4f-e063-6394a90a52412026-06-14WarningsExact identifier
unii: 70WT22SF4B
BM BM10 DROPSACID PHOS, LYCOPODIUM, NAT SULPH, OPUNTIA VULG, SYZYGIUM JAMBOL, TARAXACUM, UVA URSITotal Operations Management LLC DBA:Bestmade Natural Products Micro540fdc6a-eda2-0daf-e063-6294a90a94522026-06-12WarningsExact identifier
unii: E4GA8884NN
BM BM38 DROPSBERB AQUI, GRAPHITE, HYDROCOTYLE, KALI BROM, KALI IODAT, NATRUM PHOS, SULPHUR IODATTotal Operations Management LLC DBA:Bestmade Natural Products Micro5410af95-519a-f0d5-e063-6294a90ac0cf2026-06-12WarningsExact identifier
unii: 70WT22SF4B
BM BM68 DROPSARGENTUM NIT, BARYTA CARB., DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5410ec88-8c65-3b26-e063-6294a90adf072026-06-12WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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