DEXRAZOXANE

Product NDC
55150-437
11-digit product format
551500437
Labeler code
55150
Product ID
55150-437_f0a2a9ff-2f1f-481b-96c8-404e9d4a60fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXRAZOXANE
Dosage form
KIT
Labeler
Eugia US LLC
Application
ANDA200752
Marketing category
ANDA
Marketing start
2016-05-12
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1736585, 1736590

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
29e688b2-4dc9-4153-a703-360ac9c231b8Product name220260112
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
0acaa005-650f-0752-3fb2-220e08af175eProduct name220190219
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-437-01DEXRAZOXANE01 in 1 PACKAGEKIT013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-437-01EA - Each55150-437935de703-1cca-4e7d-89cb-1850ff8adeeb12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-437DEXRAZOXANE KIT [EUGIA US LLC]3Current NDC, Legacy NDC, 1 package rows20241109_be9ac1e9-21a9-439a-9029-9f03513220ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736585dexrazoxane 250 MG InjectionPSNbe9ac1e9-21a9-439a-9029-9f03513220ea3
1736590dexrazoxane 500 MG InjectionPSNbe9ac1e9-21a9-439a-9029-9f03513220ea3
1736585dexrazoxane 250 MG InjectionSCDbe9ac1e9-21a9-439a-9029-9f03513220ea3
1736590dexrazoxane 500 MG InjectionSCDbe9ac1e9-21a9-439a-9029-9f03513220ea3
1736590dexrazoxane (as dexrazoxane HCl) 500 MG InjectionSYbe9ac1e9-21a9-439a-9029-9f03513220ea3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55150-437-01551500437011 KIT in 1 PACKAGE (55150-437-01) * 50 mL in 1 VIAL, SINGLE-DOSE (55150-435-01) * 50 mL in 1 VIAL (55150-436-01) 1 kit2016-05-120000-00-00NoNoCurrent