Home NDC 57894-450 TECVAYLI
Product NDC 57894-450
11-digit product format 578940450
Labeler code 57894
Product ID 57894-450_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 90 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 Ingredient Strength TECLISTAMAB 90 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 54534MX6Z9 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2619432 Internal RxNorm lookup 2619438 Internal RxNorm lookup 2619441 Internal RxNorm lookup 2619444 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57894-450-01 TECVAYLI 1 in 1 CARTON INJECTION 1 16 57894-450-01 TECVAYLI 1.7 mL in 1 VIAL, SINGLE-DOSE INJECTION 1.7 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57894-450 TECVAYLI (TECLISTAMAB) INJECTION [JANSSEN BIOTECH, INC.] 12 Current NDC, Legacy NDC, 2 package rows 20241129_54e0f974-ccee-44ea-9254-40e9883cee1e.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TECVAYLI TECLISTAMAB-CQYV Janssen Biotech, Inc. 54e0f974-ccee-44ea-9254-40e9883cee1e 2026-03-10 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761291 ndc (product): 57894-450
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761291 Tecvayli teclistamab-cqyv 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 57894-450-01 57894045001 1 VIAL, SINGLE-DOSE in 1 CARTON (57894-450-01) / 1.7 mL in 1 VIAL, SINGLE-DOSE 2022-10-25 0000-00-00 No No Current