Temozolomide

Product NDC
0781-2694
11-digit product format
007812694
Labeler code
0781
Product ID
0781-2694_11eaca7f-fe49-4e46-9af8-949cca418fbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Temozolomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Sandoz Inc.
Application
NDA021029
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2013-08-12
Marketing end
0000-00-00
Substance
TEMOZOLOMIDE
Active strength
140 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-2694-44EA - Each0781-2694b5356841-9730-40c0-8411-23832d80943c12013-09-04
0781-2694-75EA - Each0781-269451e0c0ba-8036-4360-ba04-aef6f895b48d12013-09-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-2694-44007812694441 BOTTLE, GLASS in 1 CARTON (0781-2694-44) > 14 CAPSULE in 1 BOTTLE, GLASS2013-08-120000-00-00NoNoCurrent
0781-2694-75007812694751 BOTTLE, GLASS in 1 CARTON (0781-2694-75) > 5 CAPSULE in 1 BOTTLE, GLASS2013-08-120000-00-00NoNoCurrent