FDA.reportPublic FDA data

Idarubicin Hydrochloride

Product NDC
66758-055
11-digit product format
667580055
Labeler code
66758
Product ID
66758-055_615d206a-b178-4ff4-b6c1-7e349099f3c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Idarubicin Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA091293
Marketing category
ANDA
Marketing start
2011-03-29
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
E
Listing certified through
2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66758-055DDiscontinued by firm2026-08-03
excluded packagepackage66758-05566758-055-01DDiscontinued by firm2026-08-03
excluded packagepackage66758-05566758-055-03DDiscontinued by firm2026-08-03
excluded packagepackage66758-05566758-055-05DDiscontinued 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
A091293-001IDARUBICIN HYDROCHLORIDEIDARUBICIN HYDROCHLORIDE5MG/5ML (1MG/ML)SOLUTION / INTRAVENOUS2011-03-29
A091293-002IDARUBICIN HYDROCHLORIDEIDARUBICIN HYDROCHLORIDE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2011-03-29
A091293-003IDARUBICIN HYDROCHLORIDEIDARUBICIN HYDROCHLORIDE20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUS2011-03-29

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 22:54:322026-06A091293-001IDARUBICIN HYDROCHLORIDE5MG/5ML (1MG/ML)SOLUTION / INTRAVENOUS2011-03-29a50c72e98297…
2026-08-01 22:54:322026-06A091293-002IDARUBICIN HYDROCHLORIDE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUS2011-03-29a50c72e98297…
2026-08-01 22:54:322026-06A091293-003IDARUBICIN HYDROCHLORIDE20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUS2011-03-29a50c72e98297…