mitoXANTRONE

Product NDC
0703-4680
11-digit product format
007034680
Labeler code
0703
Product ID
0703-4680_4e9bdbc5-b9de-4e8e-9b0c-2f969a5a9c1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mitoXANTRONE
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Teva Parenteral Medicines, Inc.
Application
ANDA077356
Marketing category
ANDA
Marketing start
2006-04-11
Marketing end
0000-00-00
Substance
MITOXANTRONE HYDROCHLORIDE
Active strength
2 mg/mL
Pharmacologic classes
Topoisomerase Inhibitor [EPC], 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
0703-4680-01ML - Milliliter0703-4680505f1aa2-1662-4cbc-b9e9-314eca171cd512012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0703-4680-01007034680011 VIAL, MULTI-DOSE in 1 CARTON (0703-4680-01) > 12.5 mL in 1 VIAL, MULTI-DOSE2006-04-110000-00-00NoNoCurrent