Temozolomide

Product NDC
0781-2691
11-digit product format
007812691
Labeler code
0781
Product ID
0781-2691_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
5 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
0781-2691-44EA - Each0781-26915ce46f49-eccc-439e-a2c0-d6d568307fc012013-09-04
0781-2691-75EA - Each0781-26916c3b6f87-d55c-45dc-b482-7911b9e3d89a12013-09-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-2691-44007812691441 BOTTLE, GLASS in 1 CARTON (0781-2691-44) > 14 CAPSULE in 1 BOTTLE, GLASS2013-08-120000-00-00NoNoCurrent
0781-2691-75007812691751 BOTTLE, GLASS in 1 CARTON (0781-2691-75) > 5 CAPSULE in 1 BOTTLE, GLASS2013-08-120000-00-00NoNoCurrent