FDA.reportPublic FDA data

ADZYNMA

Product NDC
64764-145
11-digit product format
647640145
Labeler code
64764
Product ID
64764-145_675b72f9-d3f0-4afc-9023-7024ddfbfc30
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
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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-ad89a796d5e32024-08-30Warnings, Adverse reactionsExact identifier
application number: BLA125795
ndc (product): 64764-145

Additional Listing Data#

Finished product
Yes
Brand name base
ADZYNMA
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2670293Internal RxNorm lookup
2670300Internal RxNorm lookup
2670311Internal RxNorm lookup
2670313Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
22728e96-efa0-46c1-bdd1-ad89a796d5e3Available on FDA.report

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125795ADZYNMAADAMTS13, recombinant-krhn351(a)Rx2026-06-01

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
64764-135-01647640135011500 [iU] in 1 VIAL, SINGLE-DOSEHistorical
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