FDA.reportPublic FDA data

TALVEY

Product NDC
57894-469
11-digit product format
578940469
Labeler code
57894
Product ID
57894-469_40aadf9f-8468-bd68-e063-6394a90a32a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
talquetamab
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Janssen Biotech, Inc.
Application
BLA761342
Marketing category
BLA
Marketing start
2023-08-09
Substance
TALQUETAMAB
Active strength
3 mg/1.5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TALVEY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TALQUETAMAB3 mg/1.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4W3KFI3TN3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2644452Internal RxNorm lookup
2644458Internal RxNorm lookup
2644461Internal RxNorm lookup
2644464Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9001355e-003d-4d4e-b4ce-337e0fd14952Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2775fd8-872b-4f90-a0a1-0413a682ca35Product name120240909
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57894-469-01TALVEY1.5 mL in 1 VIAL, SINGLE-DOSEINJECTION1.55
57894-469-01TALVEY1 in 1 CARTONINJECTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57894-469-01ML - Milliliter57894-4699acd236f-c5a7-47bd-b84b-1c75a1ebafbb12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57894-469TALVEY (TALQUETAMAB) INJECTION [JANSSEN BIOTECH, INC.]4Current NDC, 2 package rows20240706_9001355e-003d-4d4e-b4ce-337e0fd14952.zip

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
TALVEYTALQUETAMABJanssen Biotech, Inc.9001355e-003d-4d4e-b4ce-337e0fd149522025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761342
ndc (product): 57894-469

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761342Talveytalquetamab-tgvs351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2644452talquetamab-tgvs 3 MG in 1.5 ML InjectionPSN9001355e-003d-4d4e-b4ce-337e0fd149525
2644461talquetamab-tgvs 40 MG in 1 ML InjectionPSN9001355e-003d-4d4e-b4ce-337e0fd149525
2644458Talvey 3 MG in 1.5 ML InjectionPSN9001355e-003d-4d4e-b4ce-337e0fd149525
2644464Talvey 40 MG in 1 ML InjectionPSN9001355e-003d-4d4e-b4ce-337e0fd149525
26444641 ML talquetamab-tgvs 40 MG/ML Injection [Talvey]SBD9001355e-003d-4d4e-b4ce-337e0fd149525
26444581.5 ML talquetamab-tgvs 2 MG/ML Injection [Talvey]SBD9001355e-003d-4d4e-b4ce-337e0fd149525
26444611 ML talquetamab-tgvs 40 MG/ML InjectionSCD9001355e-003d-4d4e-b4ce-337e0fd149525
26444521.5 ML talquetamab-tgvs 2 MG/ML InjectionSCD9001355e-003d-4d4e-b4ce-337e0fd149525
26444641 ML Talvey 40 MG/ML InjectionSY9001355e-003d-4d4e-b4ce-337e0fd149525
26444581.5 ML Talvey 2 MG/ML InjectionSY9001355e-003d-4d4e-b4ce-337e0fd149525
2644452talquetamab-tgvs 3 MG per 1.5 ML InjectionSY9001355e-003d-4d4e-b4ce-337e0fd149525
2644461talquetamab-tgvs 40 MG per 1 ML InjectionSY9001355e-003d-4d4e-b4ce-337e0fd149525
2644458Talvey 3 MG per 1.5 ML InjectionSY9001355e-003d-4d4e-b4ce-337e0fd149525
2644464Talvey 40 MG per 1 ML InjectionSY9001355e-003d-4d4e-b4ce-337e0fd149525

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
57894-469-01578940469011 VIAL, SINGLE-DOSE in 1 CARTON (57894-469-01) / 1.5 mL in 1 VIAL, SINGLE-DOSE2023-08-09NoNoCurrent