Temozolomide

Product NDC

0054-0323

11-digit product format

000540323

Labeler code

0054

Product ID

0054-0323_910d587e-5e7b-4a49-ae91-e802baf4bff0

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Temozolomide

Dosage form

CAPSULE

Route

ORAL

Labeler

Roxane Laboratories, Inc.

Application

ANDA202606

Marketing category

ANDA

Marketing start

2016-03-24

Marketing end

0000-00-00

Substance

TEMOZOLOMIDE

Active strength

140 mg/1

Pharmacologic classes

Alkylating Activity [MoA],Alkylating Drug [EPC]

NDC exclude flag

E

Listing certified through

2018-12-31

Current FDA listing

Historical FDA.report record