FDA.reportPublic FDA data

ADZYNMA

Product NDC
64764-145
Requested package NDC
64764-145-05
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#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64764-135-01ADZYNMA1500 [iU] in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,1500 [iU]1500 [iU] in 1[iU]6
64764-145-05ADZYNMA1 in 1 CARTONKIT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64764-145-05EA - Each64764-145b00c71d8-30ac-410c-90e8-2edbae08c14712023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64764-145ADZYNMA (APADAMTASE ALFA) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]6Current NDC, 2 package rows20240831_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ADZYNMAAPADAMTASE ALFATAKEDA PHARMACEUTICALS AMERICA, INC.22728e96-efa0-46c1-bdd1-ad89a796d5e32026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125795
ndc (package): 64764-145-05
ndc (product): 64764-145
ndc11 (package): 64764014505

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125795ADZYNMAADAMTS13, recombinant-krhn351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2670293ADAMTS13, recombinant-krhn 1500 UNT InjectionPSN22728e96-efa0-46c1-bdd1-ad89a796d5e36
2670311ADAMTS13, recombinant-krhn 500 UNT InjectionPSN22728e96-efa0-46c1-bdd1-ad89a796d5e36
2670300ADZYNMA 1500 UNT InjectionPSN22728e96-efa0-46c1-bdd1-ad89a796d5e36
2670313ADZYNMA 500 UNT InjectionPSN22728e96-efa0-46c1-bdd1-ad89a796d5e36
2670300ADAMTS13, recombinant-krhn 1500 UNT Injection [Adzynma]SBD22728e96-efa0-46c1-bdd1-ad89a796d5e36
2670313ADAMTS13, recombinant-krhn 500 UNT Injection [Adzynma]SBD22728e96-efa0-46c1-bdd1-ad89a796d5e36
2670293ADAMTS13, recombinant-krhn 1500 UNT InjectionSCD22728e96-efa0-46c1-bdd1-ad89a796d5e36
2670311ADAMTS13, recombinant-krhn 500 UNT InjectionSCD22728e96-efa0-46c1-bdd1-ad89a796d5e36
2670300Adzynma 1500 UNT InjectionSY22728e96-efa0-46c1-bdd1-ad89a796d5e36
2670313Adzynma 500 UNT InjectionSY22728e96-efa0-46c1-bdd1-ad89a796d5e36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64764-145-05647640145051 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 kit2023-11-09NoNoCurrent