FDA.reportPublic FDA data

Dexrazoxane

Product NDC
0143-9248
11-digit product format
001439248
Labeler code
0143
Product ID
0143-9248_032583c8-f4e7-4105-b92e-b5c3f96ca80e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexrazoxane
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA076068
Marketing category
ANDA
Marketing start
2005-03-31
Substance
DEXRAZOXANE HYDROCHLORIDE
Active strength
500 mg/1
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
A076068-001DEXRAZOXANE HYDROCHLORIDEDEXRAZOXANE HYDROCHLORIDEEQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2004-09-28
A076068-002DEXRAZOXANE HYDROCHLORIDEDEXRAZOXANE HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2004-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076068-001AP
A076068-002AP

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 22:54:322026-06A076068-001DEXRAZOXANE HYDROCHLORIDEEQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2004-09-28a50c72e98297…
2026-08-01 22:54:322026-06A076068-002DEXRAZOXANE HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2004-09-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A076068-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A076068-002AP1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DexrazoxaneDEXRAZOXANEHikma Pharmaceuticals USA Inc.68089182-d4a2-4053-8d0d-fc97a901515d2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076068
application number: ANDA076068
ndc (product): 0143-9248

Additional Listing Data#

Finished product
Yes
Brand name base
Dexrazoxane
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXRAZOXANE HYDROCHLORIDE500 mg/1

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
68089182-d4a2-4053-8d0d-fc97a901515dAvailable 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
0143-9248-01Dexrazoxane1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,18
0143-9248-01Dexrazoxane1 in 1 BOXINJECTION, POWDER, LYOPHILIZED,18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9248-01EA - Each0143-9248952ab271-ce05-4157-9325-6fb6f2f3687012018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9248DEXRAZOXANE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 2 package rows20250125_68089182-d4a2-4053-8d0d-fc97a901515d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736585dexrazoxane 250 MG InjectionPSN68089182-d4a2-4053-8d0d-fc97a901515d8
1736590dexrazoxane 500 MG InjectionPSN68089182-d4a2-4053-8d0d-fc97a901515d8
1736585dexrazoxane 250 MG InjectionSCD68089182-d4a2-4053-8d0d-fc97a901515d8
1736590dexrazoxane 500 MG InjectionSCD68089182-d4a2-4053-8d0d-fc97a901515d8
1736590dexrazoxane (as dexrazoxane HCl) 500 MG InjectionSY68089182-d4a2-4053-8d0d-fc97a901515d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9248-01001439248011 VIAL in 1 BOX (0143-9248-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL1 vial2017-10-050000-00-00NoNoCurrent