Irinotecan Hydrochloride

Product NDC
68001-425
11-digit product format
680010425
Labeler code
68001
Product ID
68001-425_f1ea10a0-5d80-4b9d-a6cf-1811d058a7f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irinotecan Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA208718
Marketing category
ANDA
Marketing start
2020-07-07
Marketing end
0000-00-00
Substance
IRINOTECAN HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-425-35680010425351 VIAL in 1 CARTON (68001-425-35) > 2 mL in 1 VIAL1 vial2020-07-070000-00-00NoNoCurrent