Home NDC 64764-145 ADZYNMA
Product NDC 64764-145
11-digit product format 647640145
Labeler code 64764
Product ID 64764-145_8053bf08-daa3-485c-916e-05c046f82c9f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Apadamtase Alfa
Dosage form KIT
Labeler TAKEDA PHARMACEUTICALS AMERICA, INC.
Application BLA125795
Marketing category BLA
Marketing start 2023-11-09
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ADZYNMA
Listing expiration 2027-12-31 DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64764-135-01 ADZYNMA 1500 [iU] in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1500 [iU] 1500 [iU] in 1[iU] 6 64764-145-05 ADZYNMA 1 in 1 CARTON KIT 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64764-145 ADZYNMA (APADAMTASE ALFA) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.] 6 Current NDC, 2 package rows 20240831_22728e96-efa0-46c1-bdd1-ad89a796d5e3.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 ADZYNMA APADAMTASE ALFA TAKEDA PHARMACEUTICALS AMERICA, INC. 22728e96-efa0-46c1-bdd1-ad89a796d5e3 2026-08-20 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125795 ndc (product): 64764-145
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125795 ADZYNMA ADAMTS13, recombinant-krhn 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64764-135-01 64764013501 1500 [iU] in 1 VIAL, SINGLE-DOSE Historical 64764-145-05 64764014505 1 KIT in 1 CARTON (64764-145-05) * 1500 [iU] in 1 VIAL, SINGLE-DOSE (64764-135-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) 1 kit 2023-11-09 No No Current