Idarubicin Hydrochloride

Product NDC
0703-4155
11-digit product format
007034155
Labeler code
0703
Product ID
0703-4155_902aa4cb-c005-480e-8275-10145b8afefe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Idarubicin Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Teva Parenteral Medicines, Inc.
Application
ANDA065036
Marketing category
ANDA
Marketing start
2002-10-01
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0703-4155-11ML - Milliliter0703-415590fd2b9e-374d-42e0-b287-44095798b33912012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0703-4155-11007034155111 VIAL, SINGLE-DOSE in 1 CARTON (0703-4155-11) > 10 mL in 1 VIAL, SINGLE-DOSE2002-10-010000-00-00NoNoCurrent