FDA.reportPublic FDA data

Dexrazoxane

Product NDC
72611-716
11-digit product format
726110716
Labeler code
72611
Product ID
72611-716_04d9a64e-d4e5-22d2-bfef-32594ee380d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexrazoxane for Injection
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Almaject, Inc.
Application
ANDA207321
Marketing category
ANDA
Marketing start
2022-06-01
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

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
ndc (product): 72611-716
DexrazoxaneDEXRAZOXANE FOR INJECTIONAlmaject, Inc.e9550d22-6069-a6de-9968-6a18c9e0448f2025-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207321
application number: ANDA207321
ndc (product): 72611-716
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

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 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
9cbd2987-10bb-eceb-153d-ee7be1ed0c84Available 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
72611-716-01Dexrazoxane50 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,506
72611-716-01Dexrazoxane1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,16
72611-716-72Dexrazoxane50 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,504
72611-716-72Dexrazoxane1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72611-716-01EA - Each72611-7166efd9d53-17df-4127-a48f-5f04feab5db012021-02-05
72611-716-72EA - Each72611-716d6406996-0227-474e-b9e5-94243d293dfe12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72611-716DEXRAZOXANE (DEXRAZOXANE FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALMAJECT, INC.]5Current NDC, Legacy NDC, 2 package rows20241006_e9550d22-6069-a6de-9968-6a18c9e0448f.zip
72611-716DEXRAZOXANE (DEXRAZOXANE FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALMAJECT, INC.]3Current NDC, Legacy NDC, 2 package rows20241009_9cbd2987-10bb-eceb-153d-ee7be1ed0c84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736590dexrazoxane 500 MG InjectionPSNe9550d22-6069-a6de-9968-6a18c9e0448f6
1736590dexrazoxane 500 MG InjectionSCDe9550d22-6069-a6de-9968-6a18c9e0448f6
1736590dexrazoxane (as dexrazoxane HCl) 500 MG InjectionSYe9550d22-6069-a6de-9968-6a18c9e0448f6
1736590dexrazoxane 500 MG InjectionPSN9cbd2987-10bb-eceb-153d-ee7be1ed0c844
1736590dexrazoxane 500 MG InjectionSCD9cbd2987-10bb-eceb-153d-ee7be1ed0c844
1736590dexrazoxane (as dexrazoxane HCl) 500 MG InjectionSY9cbd2987-10bb-eceb-153d-ee7be1ed0c844

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72611-716-01726110716011 VIAL, SINGLE-DOSE in 1 CARTON (72611-716-01) / 50 mL in 1 VIAL, SINGLE-DOSE2020-09-010000-00-00NoNoCurrent
72611-716-72726110716721 VIAL, SINGLE-DOSE in 1 CARTON (72611-716-72) / 50 mL in 1 VIAL, SINGLE-DOSE2022-06-010000-00-00NoNoCurrent