Temozolomide

Product NDC
50268-763
11-digit product format
502680763
Labeler code
50268
Product ID
50268-763_6890fc4a-df68-1d2b-e053-2a91aa0ae134
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Temozolomide
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA203691
Marketing category
ANDA
Marketing start
2017-03-23
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-763-11EA - Each50268-763ef15e399-46ab-43a2-b97e-5deed212d2a412017-05-03
50268-763-12EA - Each50268-763dc3a1c54-7e07-48b7-af4f-1d9eac549bdd12017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-763TEMOZOLOMIDE CAPSULE [AVPAK]6Legacy NDC20240110_36563b1d-61f2-43e5-b7c1-c6d9036ef28b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-763-125026807631220 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-763-12) > 1 CAPSULE in 1 BLISTER PACK (50268-763-11) 20 blister pack2017-03-230000-00-00NoNoCurrent