NDC 42737-102

TEMOZOLOMIDE

Temozolomide

TEMOZOLOMIDE is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Chemi Pharma Llc. The primary component is Temozolomide.

Product ID42737-102_b46735bd-5244-440e-96bb-b8cfef80533c
NDC42737-102
Product TypeHuman Prescription Drug
Proprietary NameTEMOZOLOMIDE
Generic NameTemozolomide
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-12-31
Marketing CategoryANDA / ANDA
Application NumberANDA204639
Labeler NameChemi Pharma LLC
Substance NameTEMOZOLOMIDE
Active Ingredient Strength20 mg/1
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 42737-102-05

1 BOTTLE, GLASS in 1 CARTON (42737-102-05) > 5 CAPSULE in 1 BOTTLE, GLASS
Marketing Start Date2018-12-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42737-102-05 [42737010205]

TEMOZOLOMIDE CAPSULE
Marketing CategoryANDA
Application NumberANDA204639
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-31
Marketing End Date2019-01-24

NDC 42737-102-14 [42737010214]

TEMOZOLOMIDE CAPSULE
Marketing CategoryANDA
Application NumberANDA204639
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-31
Marketing End Date2019-01-24

Drug Details

Active Ingredients

IngredientStrength
TEMOZOLOMIDE20 mg/1

OpenFDA Data

SPL SET ID:f2c6b5db-f26c-ea39-6905-0d0b0c134da7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 700883
  • 313209
  • 700885
  • 313210
  • 313211
  • 317160

    • Pharmacological Class

    • Alkylating Activity [MoA]
    • Alkylating Drug [EPC]