FDA.reportPublic FDA data

Dexrazoxane

Product NDC
72266-235
11-digit product format
722660235
Labeler code
72266
Product ID
72266-235_39134f54-58a4-ca41-e063-6394a90ac300
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexrazoxane for Injection
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fosun Pharma USA Inc.
Application
ANDA207321
Marketing category
ANDA
Marketing start
2021-11-01
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
DexrazoxaneDEXRAZOXANE FOR INJECTIONFosun Pharma USA Inc.c1d98fbe-5fd9-4518-b1a5-fac92e32928f2025-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207321
application number: ANDA207321
ndc (product): 72266-235

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
c1d98fbe-5fd9-4518-b1a5-fac92e32928fAvailable 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
72266-235-01Dexrazoxane25 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,258
72266-235-01Dexrazoxane1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72266-235-01EA - Each72266-235be0e7d0f-c5c6-4965-8918-9bb0cb9ce57c12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72266-235DEXRAZOXANE (DEXRAZOXANE FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FOSUN PHARMA USA INC.]7Current NDC, Legacy NDC, 2 package rows20240509_c1d98fbe-5fd9-4518-b1a5-fac92e32928f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736585dexrazoxane 250 MG InjectionPSNc1d98fbe-5fd9-4518-b1a5-fac92e32928f8
1736590dexrazoxane 500 MG InjectionPSNc1d98fbe-5fd9-4518-b1a5-fac92e32928f8
1736585dexrazoxane 250 MG InjectionSCDc1d98fbe-5fd9-4518-b1a5-fac92e32928f8
1736590dexrazoxane 500 MG InjectionSCDc1d98fbe-5fd9-4518-b1a5-fac92e32928f8
1736590dexrazoxane (as dexrazoxane HCl) 500 MG InjectionSYc1d98fbe-5fd9-4518-b1a5-fac92e32928f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72266-235-01722660235011 VIAL in 1 CARTON (72266-235-01) / 25 mL in 1 VIAL1 vial2021-11-010000-00-00NoNoCurrent