Temozolomide

Product NDC

0093-7601

11-digit product format

000937601

Labeler code

0093

Product ID

0093-7601_81643f17-65fb-4936-8b57-45aede72857a

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Temozolomide

Dosage form

CAPSULE

Route

ORAL

Labeler

Teva Pharmaceuticals USA, Inc.

Application

ANDA078879

Marketing category

ANDA

Marketing start

2013-08-12

Marketing end

0000-00-00

Substance

TEMOZOLOMIDE

Active strength

100 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