FDA.reportPublic FDA data

TECVAYLI

Product NDC
57894-449
11-digit product format
578940449
Labeler code
57894
Product ID
57894-449_5900ea09-1687-4d73-912f-5b0527cba6be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
teclistamab-cqyv
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Janssen Biotech, Inc.
Application
BLA761291
Marketing category
BLA
Marketing start
2022-10-25
Substance
TECLISTAMAB
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TECLISTAMAB10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii54534MX6Z9
Rxcui2619432, 2619438, 2619441, 2619444

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bad27da8-c83e-43dc-9edb-7ee593012bcdProduct name120240102
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
57894-449-01TECVAYLI1 in 1 CARTONINJECTION116
57894-449-01TECVAYLI3 mL in 1 VIAL, SINGLE-DOSEINJECTION316

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57894-449-01ML - Milliliter57894-44994a2530e-560d-41ec-8f0b-f00b88de110712022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57894-449TECVAYLI (TECLISTAMAB) INJECTION [JANSSEN BIOTECH, INC.]12Current NDC, Legacy NDC, 2 package rows20241129_54e0f974-ccee-44ea-9254-40e9883cee1e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2619441teclistamab-cqyv 153 MG in 1.7 ML InjectionPSN54e0f974-ccee-44ea-9254-40e9883cee1e16
2619432teclistamab-cqyv 30 MG in 3 ML InjectionPSN54e0f974-ccee-44ea-9254-40e9883cee1e16
2619444TECVAYLI 153 MG in 1.7 ML InjectionPSN54e0f974-ccee-44ea-9254-40e9883cee1e16
2619438TECVAYLI 30 MG in 3 ML InjectionPSN54e0f974-ccee-44ea-9254-40e9883cee1e16
26194441.7 ML teclistamab-cqyv 90 MG/ML Injection [Tecvayli]SBD54e0f974-ccee-44ea-9254-40e9883cee1e16
26194383 ML teclistamab-cqyv 10 MG/ML Injection [Tecvayli]SBD54e0f974-ccee-44ea-9254-40e9883cee1e16
26194411.7 ML teclistamab-cqyv 90 MG/ML InjectionSCD54e0f974-ccee-44ea-9254-40e9883cee1e16
26194323 ML teclistamab-cqyv 10 MG/ML InjectionSCD54e0f974-ccee-44ea-9254-40e9883cee1e16
26194441.7 ML Tecvayli 90 MG/ML InjectionSY54e0f974-ccee-44ea-9254-40e9883cee1e16
26194383 ML Tecvayli 10 MG/ML InjectionSY54e0f974-ccee-44ea-9254-40e9883cee1e16
2619441teclistamab-cqyv 153 MG per 1.7 ML InjectionSY54e0f974-ccee-44ea-9254-40e9883cee1e16
2619432teclistamab-cqyv 30 MG per 3 ML InjectionSY54e0f974-ccee-44ea-9254-40e9883cee1e16
2619444Tecvayli 153 MG per 1.7 ML InjectionSY54e0f974-ccee-44ea-9254-40e9883cee1e16
2619438Tecvayli 30 MG per 3 ML InjectionSY54e0f974-ccee-44ea-9254-40e9883cee1e16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57894-449-01578940449011 VIAL, SINGLE-DOSE in 1 CARTON (57894-449-01) / 3 mL in 1 VIAL, SINGLE-DOSE2022-10-250000-00-00NoNoCurrent