FDA.reportPublic FDA data

Idarubicin Hydrochloride

Product NDC
0143-9219
11-digit product format
001439219
Labeler code
0143
Product ID
0143-9219_894003f2-e5ea-430f-9450-aae8a493664e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Idarubicin Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065275
Marketing category
ANDA
Marketing start
2017-01-30
Substance
IDARUBICIN HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065275-001IDARUBICIN HYDROCHLORIDEIDARUBICIN HYDROCHLORIDE5MG/5ML (1MG/ML)SOLUTION / INTRAVENOUSAP2006-12-14
A065275-002IDARUBICIN HYDROCHLORIDEIDARUBICIN HYDROCHLORIDE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2006-12-14
A065275-003IDARUBICIN HYDROCHLORIDEIDARUBICIN HYDROCHLORIDE20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAP2006-12-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A065275-001AP
A065275-002AP
A065275-003AP

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 22:54:322026-06A065275-001IDARUBICIN HYDROCHLORIDE5MG/5ML (1MG/ML)SOLUTION / INTRAVENOUSAP2006-12-14a50c72e98297…
2026-08-01 22:54:322026-06A065275-002IDARUBICIN HYDROCHLORIDE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2006-12-14a50c72e98297…
2026-08-01 22:54:322026-06A065275-003IDARUBICIN HYDROCHLORIDE20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAP2006-12-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A065275-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A065275-002AP1a50c72e98297…
2026-08-01 22:54:322026-06A065275-003AP1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Idarubicin HydrochlorideIDARUBICIN HYDROCHLORIDEHikma Pharmaceuticals USA Inc.7c20b574-285b-49eb-a98e-6752e4bb481d2025-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065275
application number: ANDA065275
Idarubicin HydrochlorideIDARUBICIN HYDROCHLORIDEHikma Pharmaceuticals USA Inc.b9b337d5-50f7-4ea9-9df4-72c86e4c0b912023-04-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065275
application number: ANDA065275
ndc (product): 0143-9219

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IDARUBICIN HYDROCHLORIDE1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5VV3MDU5IEInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1791493Internal RxNorm lookup
1791498Internal RxNorm lookup
1791500Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b9b337d5-50f7-4ea9-9df4-72c86e4c0b91Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9219-01Idarubicin Hydrochloride20 mL in 1 VIAL, GLASSINJECTION, SOLUTION208
0143-9219-01Idarubicin Hydrochloride1 in 1 BOXINJECTION, SOLUTION18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9219-01ML - Milliliter0143-9219357bcd5b-9829-4fe9-8691-af35dd4b6ade12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9219IDARUBICIN HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 2 package rows20230420_b9b337d5-50f7-4ea9-9df4-72c86e4c0b91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791498IDArubicin HCl 10 MG in 10 ML InjectionPSNb9b337d5-50f7-4ea9-9df4-72c86e4c0b918
1791493IDArubicin HCl 20 MG in 20 ML InjectionPSNb9b337d5-50f7-4ea9-9df4-72c86e4c0b918
1791500IDArubicin HCl 5 MG in 5 ML InjectionPSNb9b337d5-50f7-4ea9-9df4-72c86e4c0b918
179149810 ML idarubicin hydrochloride 1 MG/ML InjectionSCDb9b337d5-50f7-4ea9-9df4-72c86e4c0b918
179149320 ML idarubicin hydrochloride 1 MG/ML InjectionSCDb9b337d5-50f7-4ea9-9df4-72c86e4c0b918
17915005 ML idarubicin hydrochloride 1 MG/ML InjectionSCDb9b337d5-50f7-4ea9-9df4-72c86e4c0b918
1791498idarubicin HCl 10 MG per 10 ML InjectionSYb9b337d5-50f7-4ea9-9df4-72c86e4c0b918
1791493idarubicin HCl 20 MG per 20 ML InjectionSYb9b337d5-50f7-4ea9-9df4-72c86e4c0b918
1791500idarubicin HCl 5 MG per 5 ML InjectionSYb9b337d5-50f7-4ea9-9df4-72c86e4c0b918

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0143-9219-01001439219011 VIAL, GLASS in 1 BOX (0143-9219-01) / 20 mL in 1 VIAL, GLASS2017-01-300000-00-00NoNoCurrent