FDA.reportPublic FDA data

Dexrazoxane

Product NDC
68083-388
11-digit product format
680830388
Labeler code
68083
Product ID
68083-388_31a8c608-3ad6-44fe-aec8-621a8b991677
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexrazoxane for Injection
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA207321
Marketing category
ANDA
Marketing start
2019-12-16
Substance
DEXRAZOXANE HYDROCHLORIDE
Active strength
250 mg/25mL
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 HYDROCHLORIDE250 mg/25mL

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
68083-388-01Dexrazoxane25 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,256
68083-388-01Dexrazoxane01 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-388DEXRAZOXANE (DEXRAZOXANE FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED]5Current NDC, 2 package rows20231214_c9c625fc-8852-4ed4-bcf2-63f46a706782.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736585dexrazoxane 250 MG InjectionPSNc9c625fc-8852-4ed4-bcf2-63f46a7067826
1736590dexrazoxane 500 MG InjectionPSNc9c625fc-8852-4ed4-bcf2-63f46a7067826
1736585dexrazoxane 250 MG InjectionSCDc9c625fc-8852-4ed4-bcf2-63f46a7067826
1736590dexrazoxane 500 MG InjectionSCDc9c625fc-8852-4ed4-bcf2-63f46a7067826
1736590dexrazoxane (as dexrazoxane HCl) 500 MG InjectionSYc9c625fc-8852-4ed4-bcf2-63f46a7067826

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68083-388-01680830388011 VIAL in 1 CARTON (68083-388-01) / 25 mL in 1 VIAL1 vial2019-12-16NoNoCurrent