Temozolomide

Product NDC
0781-2692
11-digit product format
007812692
Labeler code
0781
Product ID
0781-2692_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
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-2692-44EA - Each0781-2692028f7a13-bb32-4c05-8896-6c4d5af67e2812013-09-04
0781-2692-75EA - Each0781-2692b58f6c55-b419-4f76-b5e6-e17d79ac5a4712013-09-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-2692-44007812692441 BOTTLE, GLASS in 1 CARTON (0781-2692-44) > 14 CAPSULE in 1 BOTTLE, GLASS2013-08-120000-00-00NoNoCurrent
0781-2692-75007812692751 BOTTLE, GLASS in 1 CARTON (0781-2692-75) > 5 CAPSULE in 1 BOTTLE, GLASS2013-08-120000-00-00NoNoCurrent