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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207321-001DEXRAZOXANE HYDROCHLORIDEDEXRAZOXANE HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2016-11-28
A207321-002DEXRAZOXANE HYDROCHLORIDEDEXRAZOXANE HYDROCHLORIDEEQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2019-12-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A207321-001AP
A207321-002AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A207321-001DEXRAZOXANE HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2016-11-28a50c72e98297…
2026-08-01 22:54:322026-06A207321-002DEXRAZOXANE HYDROCHLORIDEEQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2019-12-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207321-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A207321-002AP1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DexrazoxaneDEXRAZOXANE FOR INJECTIONAlmaject, Inc.9cbd2987-10bb-eceb-153d-ee7be1ed0c842025-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207321
application number: ANDA207321
DexrazoxaneDEXRAZOXANE FOR INJECTIONAlmaject, Inc.e9550d22-6069-a6de-9968-6a18c9e0448f2025-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207321
application number: ANDA207321
DexrazoxaneDEXRAZOXANE FOR INJECTIONGland Pharma Limitedc9c625fc-8852-4ed4-bcf2-63f46a7067822025-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207321
application number: ANDA207321
ndc (product): 68083-388
DexrazoxaneDEXRAZOXANE FOR INJECTIONFosun Pharma USA Inc.c1d98fbe-5fd9-4518-b1a5-fac92e32928f2025-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207321
application number: ANDA207321

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5346058Q7SInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1736585Internal RxNorm lookup
1736590Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c9c625fc-8852-4ed4-bcf2-63f46a706782Available on FDA.report

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