Irinotecan Hydrochloride

Product NDC
68001-284
11-digit product format
680010284
Labeler code
68001
Product ID
68001-284_952bfc0f-6e66-426f-b3d5-7d9d6e81b8ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irinotecan Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA077219
Marketing category
ANDA
Marketing start
2008-02-20
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-284-22ML - Milliliter68001-284332852cc-aff6-402b-92a2-8480c485688812016-07-19
68001-284-25ML - Milliliter68001-2843efe0095-9664-46d8-9bf9-bbdc819bdf0712016-07-19
68001-284-34ML - Milliliter68001-2848cc7772a-5fb8-4b24-9b84-9983a0160e6e12016-07-19
68001-284-35ML - Milliliter68001-2840a950f97-bd0d-4817-b390-5916388fdb9f12016-07-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-284-25680010284251 VIAL in 1 CARTON (68001-284-25) > 5 mL in 1 VIAL (68001-284-22) 1 vial2016-05-310000-00-00NoNoCurrent
68001-284-34680010284341 VIAL in 1 CARTON (68001-284-34) > 2 mL in 1 VIAL (68001-284-35) 1 vial2016-05-310000-00-00NoNoCurrent