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

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