Temozolomide

Product NDC
0781-2693
11-digit product format
007812693
Labeler code
0781
Product ID
0781-2693_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
100 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
0781-2693-44EA - Each0781-26931d014dae-f382-49a4-8360-4937c5bf3b5e12013-09-04
0781-2693-75EA - Each0781-2693a581eb62-f0e2-4996-9bd5-fcc3b4a1e8c212013-09-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-2693-44007812693441 BOTTLE, GLASS in 1 CARTON (0781-2693-44) > 14 CAPSULE in 1 BOTTLE, GLASS2013-08-120000-00-00NoNoCurrent
0781-2693-75007812693751 BOTTLE, GLASS in 1 CARTON (0781-2693-75) > 5 CAPSULE in 1 BOTTLE, GLASS2013-08-120000-00-00NoNoCurrent