FDA.reportPublic FDA data

Idarubicin Hydrochloride

Product NDC
63323-194
11-digit product format
633230194
Labeler code
63323
Product ID
63323-194_23c8614b-c992-4842-9807-c5681c099546
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IDARUBICIN HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA065440
Marketing category
ANDA
Marketing start
2009-08-11
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63323-194DDiscontinued by firm2026-08-03
excluded packagepackage63323-19463323-194-20DDiscontinued by firm2026-08-03

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
A065440-001IDARUBICIN HYDROCHLORIDEIDARUBICIN HYDROCHLORIDE5MG/5ML (1MG/ML)SOLUTION / INTRAVENOUS2009-08-04
A065440-002IDARUBICIN HYDROCHLORIDEIDARUBICIN HYDROCHLORIDE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2009-08-04
A065440-003IDARUBICIN HYDROCHLORIDEIDARUBICIN HYDROCHLORIDE20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUS2009-08-04

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 22:54:322026-06A065440-001IDARUBICIN HYDROCHLORIDE5MG/5ML (1MG/ML)SOLUTION / INTRAVENOUS2009-08-04a50c72e98297…
2026-08-01 22:54:322026-06A065440-002IDARUBICIN HYDROCHLORIDE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2009-08-04a50c72e98297…
2026-08-01 22:54:322026-06A065440-003IDARUBICIN HYDROCHLORIDE20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUS2009-08-04a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-194-05ML - Milliliter63323-194c3bc4d48-618b-4381-b5be-ce6e47d5f72c12012-07-24
63323-194-10ML - Milliliter63323-1942ddf230f-6a0d-49ba-aae9-02378ddc826112012-07-24
63323-194-20ML - Milliliter63323-19447c3b2a6-a499-4223-acc8-7c926c4d814012012-07-24