TEMOZOLOMIDE

Product NDC
64980-338
11-digit product format
649800338
Labeler code
64980
Product ID
64980-338_1c22f9d0-ae27-4e69-8b33-e634071128e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temozolomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharmaceuticals, Inc.
Application
ANDA206309
Marketing category
ANDA
Marketing start
2017-03-17
Marketing end
0000-00-00
Substance
TEMOZOLOMIDE
Active strength
250 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
64980-338-05EA - Each64980-338d6262d55-41ae-4469-a92a-dfd0f1a75ab612017-06-15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-338-05649800338055 CAPSULE in 1 BOTTLE, PLASTIC (64980-338-05) 5 capsule2017-03-170000-00-00NoNoCurrent