Home NDC 73535-208 MONJUVI
Product NDC 73535-208
11-digit product format 735350208
Labeler code 73535
Product ID 73535-208_49d73fc8-03e2-8b9c-e063-6294a90a3a97
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tafasitamab-cxix
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Incyte Corporation
Application BLA761163
Marketing category BLA
Marketing start 2020-08-05
Substance TAFASITAMAB
Active strength 200 mg/5mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 73535-208 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 73535-208 73535-208-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Additional Listing Data#
Finished product Yes
Brand name base MONJUVI
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TAFASITAMAB 200 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination QQA9MLH692 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2387338 Internal RxNorm lookup 2387343 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 73535-208-01 MONJUVI 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 10 73535-208-01 MONJUVI 5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 5 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73535-208 MONJUVI (TAFASITAMAB-CXIX) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [INCYTE CORPORATION] 8 Current NDC, Legacy NDC, 2 package rows 20241016_ec13ac6b-bfde-4e84-907a-83bd69584d95.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 · 2 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761163 Monjuvi tafasitamab-cxix 351(a) Rx 2026-08-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 73535-208-01 73535020801 1 VIAL in 1 CARTON (73535-208-01) / 5 mL in 1 VIAL 1 vial 2020-08-05 0000-00-00 No No Current