FDA.reportPublic FDA data

Dexrazoxane

Product NDC
72205-248
11-digit product format
722050248
Labeler code
72205
Product ID
72205-248_bdcb7617-046b-4db9-94ba-b10102565868
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexrazoxane
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA216748
Marketing category
ANDA
Marketing start
2025-03-26
Substance
DEXRAZOXANE HYDROCHLORIDE
Active strength
500 mg/50mL
Pharmacologic classes
Cytoprotective Agent [EPC]
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXRAZOXANE HYDROCHLORIDE500 mg/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5346058Q7S
Rxcui1736585, 1736590

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
29e688b2-4dc9-4153-a703-360ac9c231b8Product name220260112
0acaa005-650f-0752-3fb2-220e08af175eProduct name220190219

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-248-01Dexrazoxane50 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,502
72205-248-01Dexrazoxane1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-248-01EA - Each72205-24896c2f8af-4d0a-448b-84e3-73c68987653712025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-248DEXRAZOXANE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, 2 package rows20250410_a7c01089-85f5-40aa-b679-f53a425b4d68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736585dexrazoxane 250 MG InjectionPSNa7c01089-85f5-40aa-b679-f53a425b4d682
1736590dexrazoxane 500 MG InjectionPSNa7c01089-85f5-40aa-b679-f53a425b4d682
1736585dexrazoxane 250 MG InjectionSCDa7c01089-85f5-40aa-b679-f53a425b4d682
1736590dexrazoxane 500 MG InjectionSCDa7c01089-85f5-40aa-b679-f53a425b4d682
1736590dexrazoxane (as dexrazoxane HCl) 500 MG InjectionSYa7c01089-85f5-40aa-b679-f53a425b4d682

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72205-248-01722050248011 VIAL, SINGLE-DOSE in 1 CARTON (72205-248-01) / 50 mL in 1 VIAL, SINGLE-DOSE2025-04-09NoNoCurrent