FDA.reportPublic FDA data

Zolgensma

Product NDC
71894-125
11-digit product format
718940125
Labeler code
71894
Product ID
71894-125_f1dde092-6024-41c8-8006-77e19ef21ec1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
onasemnogene abeparvovec-xioi
Dosage form
KIT
Labeler
Novartis Gene Therapies, Inc.
Application
BLA125694
Marketing category
BLA
Marketing start
2019-05-24
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZolgensmaONASEMNOGENE ABEPARVOVEC-XIOINovartis Innovative Technologies Inc.68cd4f06-70e1-40d8-bedb-609ec0afa4712026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125694
ndc (product): 71894-125

Additional Listing Data#

Finished product
Yes
Brand name base
Zolgensma
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 4 · 79 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup
2170239Internal RxNorm lookup
2170241Internal RxNorm lookup
2170244Internal RxNorm lookup
2170245Internal RxNorm lookup
2170246Internal RxNorm lookup
2170247Internal RxNorm lookup
2170248Internal RxNorm lookup
2170249Internal RxNorm lookup
2170250Internal RxNorm lookup
2170251Internal RxNorm lookup
2170252Internal RxNorm lookup
2170253Internal RxNorm lookup
2170254Internal RxNorm lookup
2170255Internal RxNorm lookup
2170256Internal RxNorm lookup
2170257Internal RxNorm lookup
2170258Internal RxNorm lookup
2170259Internal RxNorm lookup
2170260Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
68cd4f06-70e1-40d8-bedb-609ec0afa471Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71894-110-01Zolgensma5.5 mL in 1 VIALINJECTION, SUSPENSION5.5 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION24.9 mL20000000000000 [arb'U] in 1mL14
71894-125-04Zolgensma1 in 1 CARTONKIT114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71894-125-04EA - Each71894-125fb04365e-f066-461e-847a-5342a5d4d8f312019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71894-125ZOLGENSMA (ONASEMNOGENE ABEPARVOVEC-XIOI) KIT [NOVARTIS GENE THERAPIES, INC.]13Current NDC, Legacy NDC, 3 package rows20250214_68cd4f06-70e1-40d8-bedb-609ec0afa471.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125694Zolgensmaonasemnogene abeparvovec-xioi351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2630855{1 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) / 10 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 15.6 - 16.0 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630858{1 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) / 11 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 17.1 - 17.5 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630861{1 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) / 12 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 18.6 - 19.0 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630864{1 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) / 13 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 20.1 - 20.5 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170249{1 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) / 2 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 3.6 - 4.0 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170289{1 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) / 3 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 5.1 - 5.5 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170295{1 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) / 4 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 6.6 - 7.0 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170279{1 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) / 5 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 8.1 - 8.5 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170259{1 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) / 6 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 9.6 - 10.0 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170265{1 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) / 7 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 11.1 - 11.5 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170297{1 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) / 8 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 12.6 - 13.0 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630833{1 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) / 9 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 14.1 - 14.5 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630839{10 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 14.6 - 15.0 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630856{11 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 16.1 - 16.5 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630859{12 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 17.6 - 18.0 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630862{13 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 19.1 - 19.5 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630865{14 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 20.6 - 21.0 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170247{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) / 1 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 3.1 - 3.5 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630857{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) / 10 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 16.6 - 17.0 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630860{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) / 11 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 18.1 - 18.5 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630863{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) / 12 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 19.6 - 20.0 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170253{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) / 2 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 4.6 - 5.0 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170293{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) / 3 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 6.1 - 6.5 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170276{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) / 4 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 7.6 - 8.0 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170284{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) / 5 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 9.1 - 9.5 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170263{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) / 6 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 10.6 - 11.0 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170274{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) / 7 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 12.1 - 12.5 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630832{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) / 8 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 13.6 - 14.0 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630840{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) / 9 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 15.1 - 15.5 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170255{2 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 2.6 - 3.0 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170251{3 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 4.1 - 4.5 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170291{4 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 5.6 - 6.0 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170272{5 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 7.1 - 7.5 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170282{6 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 8.6 - 9.0 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170261{7 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 10.1 - 10.5 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170267{8 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 11.6 - 12.0 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170257{9 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]) } Pack [Zolgensma Kit 13.1 - 13.5 kg]BPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630769{1 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 10 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630775{1 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 11 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630781{1 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 12 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630787{1 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 13 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170248{1 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 2 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170288{1 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 3 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170294{1 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 4 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170278{1 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 5 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170258{1 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 6 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170264{1 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 7 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170296{1 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 8 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630763{1 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 9 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630765{10 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630771{11 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630777{12 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630783{13 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630790{14 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170245{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 1 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630773{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 10 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630779{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 11 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630785{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 12 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170252{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 2 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170292{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 3 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170275{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 4 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170283{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 5 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170262{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 6 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170273{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 7 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630761{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 8 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2630767{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 9 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170254{2 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170250{3 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170290{4 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170270{5 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170281{6 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170260{7 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170266{8 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170256{9 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK68cd4f06-70e1-40d8-bedb-609ec0afa47114
797544isopropyl alcohol 70 % Medicated PadPSN68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170239onasemnogene abeparvovec-xioi 2 x 10(13) vg/ML in 5.5 ML InjectionPSN68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170244onasemnogene abeparvovec-xioi 2 x 10(13) vg/ML in 8.3 ML InjectionPSN68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170260onasemnogene abeparvovec-xioi Kit Patient Weight 10.1 - 10.5 KGPSN68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170262onasemnogene abeparvovec-xioi Kit Patient Weight 10.6 - 11.0 KGPSN68cd4f06-70e1-40d8-bedb-609ec0afa47114
2170264onasemnogene abeparvovec-xioi Kit Patient Weight 11.1 - 11.5 KGPSN68cd4f06-70e1-40d8-bedb-609ec0afa47114

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71894-110-01718940110015.5 mL in 1 VIAL5.5 mlHistorical
71894-115-01718940115018.3 mL in 1 VIAL8.3 mlHistorical
71894-125-04718940125041 KIT in 1 CARTON (71894-125-04) * 8.3 mL in 1 VIAL (71894-115-01) * 1 mL in 1 POUCH * 5.5 mL in 1 VIAL (71894-110-01) 1 kit2019-05-240000-00-00NoNoCurrent