Temozolomide

Product NDC
62559-924
11-digit product format
625590924
Labeler code
62559
Product ID
62559-924_ea20ab6a-6558-4114-8983-c8df85adff0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Temozolomide
Dosage form
CAPSULE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA203490
Marketing category
ANDA
Marketing start
2020-11-16
Marketing end
2023-02-28
Substance
TEMOZOLOMIDE
Active strength
180 mg/1
Pharmacologic classes
Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62559-924-14625590924141 BOTTLE, GLASS in 1 CARTON (62559-924-14) > 14 CAPSULE in 1 BOTTLE, GLASS2020-11-160000-00-00NoNoCurrent
62559-924-51625590924511 BOTTLE, GLASS in 1 CARTON (62559-924-51) > 5 CAPSULE in 1 BOTTLE, GLASS2020-11-160000-00-00NoNoCurrent