temozolomide

Product NDC
70771-1093
11-digit product format
707711093
Labeler code
70771
Product ID
70771-1093_84b259e3-d098-4384-8e3d-d498ba589408
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temozolomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA206750
Marketing category
ANDA
Marketing start
2017-10-26
Marketing end
0000-00-00
Substance
TEMOZOLOMIDE
Active strength
20 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
70771-1093-6707711093065 CAPSULE in 1 BOTTLE (70771-1093-6) 5 capsule2017-10-260000-00-00NoNoCurrent
70771-1093-77077110930714 CAPSULE in 1 BOTTLE (70771-1093-7) 14 capsule2017-10-260000-00-00NoNoCurrent