FDA.reportPublic FDA data

ITVISMA

Product NDC
71894-200
11-digit product format
718940200
Labeler code
71894
Product ID
71894-200_ab2e1c6c-4f95-4243-9296-1734e0a30591
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
onasemnogene abeparvovec-brve
Dosage form
INJECTION, SUSPENSION
Route
INTRATHECAL
Labeler
Novartis Gene Therapies, 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
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
ITVISMAONASEMNOGENE ABEPARVOVEC-BRVENovartis Innovative Technologies Inc.ab2e1c6c-4f95-4243-9296-1734e0a305912026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125856
ndc (product): 71894-200

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125856ITVISMAonasemnogene abeparvovec-brve351(a)Rx2026-06-01

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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
71894-200-01718940200013 mL in 1 VIAL, SINGLE-DOSE3 mlHistorical
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