TEMODAR - 0085-1381-01 - (Temozolomide)

Alphabetical Index


Drug Information of TEMODAR

Product NDC: 0085-1381
Proprietary Name: TEMODAR
Non Proprietary Name: Temozolomide
Active Ingredient(s): 2.5    mg/mL & nbsp;   Temozolomide
Administration Route(s): INTRAVENOUS
Dosage Form(s): INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Coding System: National Drug Codes(NDC)

Labeler Information of TEMODAR

Product NDC: 0085-1381
Labeler Name: Merck Sharp & Dohme Corp.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA022277
Marketing Category: NDA
Start Marketing Date: 20090227

Package Information of TEMODAR

Package NDC: 0085-1381-01
Package Description: 1 VIAL, SINGLE-USE in 1 CARTON (0085-1381-01) > 40 mL in 1 VIAL, SINGLE-USE

NDC Information of TEMODAR

NDC Code 0085-1381-01
Proprietary Name TEMODAR
Package Description 1 VIAL, SINGLE-USE in 1 CARTON (0085-1381-01) > 40 mL in 1 VIAL, SINGLE-USE
Product NDC 0085-1381
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Temozolomide
Dosage Form Name INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route Name INTRAVENOUS
Start Marketing Date 20090227
Marketing Category Name NDA
Labeler Name Merck Sharp & Dohme Corp.
Substance Name TEMOZOLOMIDE
Strength Number 2.5
Strength Unit mg/mL
Pharmaceutical Classes Alkylating Activity [MoA],Alkylating Drug [EPC]

Complete Information of TEMODAR


General Information