FDA.reportPublic FDA data

ITVISMA

Product NDC
71894-200
Requested package NDC
71894-200-02
11-digit product format
718940200
Labeler code
71894
Product ID
71894-200_68c25df1-ad2d-4bb0-8e19-e9a58b868d13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
onasemnogene abeparvovec-brve
Dosage form
INJECTION, SUSPENSION
Route
INTRATHECAL
Labeler
Novartis Innovative Technologies Inc.
Application
BLA125856
Marketing category
BLA
Marketing start
2025-11-24
Substance
ONASEMNOGENE ABEPARVOVEC
Active strength
40000000000000 [arb'U]/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONASEMNOGENE ABEPARVOVEC40000000000000 [arb'U]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MLU3LU3EVVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2727307Internal RxNorm lookup
2727314Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ab2e1c6c-4f95-4243-9296-1734e0a30591Available 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
71894-200-01ITVISMA3 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION31
71894-200-02ITVISMA1 in 1 CARTONINJECTION, SUSPENSION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71894-200-01EA - Each71894-200c4fc7577-0a06-4434-ad8b-ae0fcda8047e22026-01-08
71894-200-02EA - Each71894-200d94035bd-2630-42ab-8286-6800a0185e4d22026-02-05

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ITVISMAONASEMNOGENE ABEPARVOVEC-BRVENovartis Innovative Technologies Inc.ab2e1c6c-4f95-4243-9296-1734e0a305912026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125856
ndc (package): 71894-200-02
ndc (product): 71894-200
ndc11 (package): 71894020002

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125856ITVISMAonasemnogene abeparvovec-brve351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2727314itvisma 1.2 x 10(14) vector genomes in 3 ML InjectionPSNab2e1c6c-4f95-4243-9296-1734e0a305911
2727307onasemnogene abeparvovec-brve 1.2 x 10(14) vector genomes in 3 ML InjectionPSNab2e1c6c-4f95-4243-9296-1734e0a305911
27273143 ML onasemnogene abeparvovec-brve 40000000000000 VECTOR-GENOMES/ML Injection [Itvisma]SBDab2e1c6c-4f95-4243-9296-1734e0a305911
27273073 ML onasemnogene abeparvovec-brve 40000000000000 VECTOR-GENOMES/ML InjectionSCDab2e1c6c-4f95-4243-9296-1734e0a305911
2727314itvisma 1.2 x 10(14) vector genomes in 3 ML InjectionSYab2e1c6c-4f95-4243-9296-1734e0a305911
2727314itvisma 4 x 10(13) vg/ML per 3 ML InjectionSYab2e1c6c-4f95-4243-9296-1734e0a305911
2727307onasemnogene abeparvovec-brve 1.2 x 10(14) vector genomes per 3 ML InjectionSYab2e1c6c-4f95-4243-9296-1734e0a305911
2727307onasemnogene abeparvovec-brve 4 x 10(13) vg/ML per 3 ML InjectionSYab2e1c6c-4f95-4243-9296-1734e0a305911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71894-200-02718940200021 VIAL, SINGLE-DOSE in 1 CARTON (71894-200-02) / 3 mL in 1 VIAL, SINGLE-DOSE (71894-200-01) 2025-11-24NoNoCurrent