Temozolomide

Product NDC
23155-774
11-digit product format
231550774
Labeler code
23155
Product ID
23155-774_e1982c81-2588-45cf-94f7-160a700709e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Temozolomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA078879
Marketing category
ANDA
Marketing start
2022-06-15
Marketing end
0000-00-00
Substance
TEMOZOLOMIDE
Active strength
5 mg/1
Pharmacologic classes
Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-774-71231550774715 CAPSULE in 1 BOTTLE (23155-774-71) 5 capsule2022-06-150000-00-00NoNoCurrent
23155-774-722315507747214 CAPSULE in 1 BOTTLE (23155-774-72) 14 capsule2022-06-150000-00-00NoNoCurrent