Irinotecan Hydrochloride

Product NDC
0703-4432
11-digit product format
007034432
Labeler code
0703
Product ID
0703-4432_44fdc8cc-0d13-4b49-b79d-81bbb93c67c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irinotecan Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Teva Parenteral Medicines, Inc.
Application
ANDA090101
Marketing category
ANDA
Marketing start
2008-02-28
Marketing end
2019-11-30
Substance
IRINOTECAN HYDROCHLORIDE
Active strength
40 mg/2mL
Pharmacologic classes
Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0703-4432-11ML - Milliliter0703-4432028089a0-2a9a-4cb3-9273-2d804d1901e512012-07-24
0703-4432-81ML - Milliliter0703-4432144a1bc8-751f-4083-82b9-80b8b43e84cf12015-08-04