TEMOZOLOMIDE

Product NDC
42737-105
11-digit product format
427370105
Labeler code
42737
Product ID
42737-105_b46735bd-5244-440e-96bb-b8cfef80533c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temozolomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Chemi Pharma LLC
Application
ANDA204639
Marketing category
ANDA
Marketing start
2018-12-31
Marketing end
0000-00-00
Substance
TEMOZOLOMIDE
Active strength
180 mg/1
Pharmacologic classes
Alkylating Activity [MoA],Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record