NDC 0054-0323

Temozolomide

Temozolomide

Temozolomide is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Roxane Laboratories, Inc.. The primary component is Temozolomide.

Product ID0054-0323_910d587e-5e7b-4a49-ae91-e802baf4bff0
NDC0054-0323
Product TypeHuman Prescription Drug
Proprietary NameTemozolomide
Generic NameTemozolomide
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2016-03-24
Marketing CategoryANDA / ANDA
Application NumberANDA202606
Labeler NameRoxane Laboratories, Inc.
Substance NameTEMOZOLOMIDE
Active Ingredient Strength140 mg/1
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC SPL Data Element Entries

NDC 0054-0323-03 [00054032303]

Temozolomide CAPSULE
Marketing CategoryANDA
Application NumberANDA202606
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-03-24
Marketing End Date2016-03-24

NDC 0054-0323-06 [00054032306]

Temozolomide CAPSULE
Marketing CategoryANDA
Application NumberANDA202606
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-03-24
Marketing End Date2016-03-24

Drug Details

Active Ingredients

IngredientStrength
TEMOZOLOMIDE140 mg/1

OpenFDA Data

SPL SET ID:8f140343-1ddb-4346-a051-ad43f475c92b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 700883
  • 313209
  • 700885
  • 313210
  • 313211
  • 317160
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Temozolomide" or generic name "Temozolomide"

    NDCBrand NameGeneric Name
    0054-0320TemozolomideTemozolomide
    0054-0321TemozolomideTemozolomide
    0054-0322TemozolomideTemozolomide
    0054-0323TemozolomideTemozolomide
    0054-0324TemozolomideTemozolomide
    0054-0325TemozolomideTemozolomide
    0093-7599TemozolomideTemozolomide
    0093-7600TemozolomideTemozolomide
    67877-537TemozolomideTemozolomide
    67877-539TemozolomideTemozolomide
    67877-540TemozolomideTemozolomide
    67877-541TemozolomideTemozolomide
    67877-542TemozolomideTemozolomide
    67877-538TemozolomideTemozolomide
    68382-751temozolomidetemozolomide
    68382-753temozolomidetemozolomide
    68382-756temozolomidetemozolomide
    68382-754temozolomidetemozolomide
    68382-755temozolomidetemozolomide
    68382-752temozolomidetemozolomide
    70771-1096temozolomidetemozolomide
    70771-1092temozolomidetemozolomide
    70771-1094temozolomidetemozolomide
    70771-1095temozolomidetemozolomide
    70771-1097temozolomidetemozolomide
    70771-1093temozolomidetemozolomide
    0781-2694TemozolomideTemozolomide
    0781-2691TemozolomideTemozolomide
    0781-2692TemozolomideTemozolomide
    0781-2696TemozolomideTemozolomide
    0781-2695TemozolomideTemozolomide
    0781-2693TemozolomideTemozolomide
    0093-7602TemozolomideTemozolomide
    0093-7639TemozolomideTemozolomide
    16729-130TemozolomideTemozolomide
    16729-049TemozolomideTemozolomide
    16729-050TemozolomideTemozolomide
    0093-7601TemozolomideTemozolomide
    0093-7638TemozolomideTemozolomide
    16729-129TemozolomideTemozolomide
    16729-051TemozolomideTemozolomide
    16729-048TemozolomideTemozolomide
    42737-101TEMOZOLOMIDETEMOZOLOMIDE
    42737-103TEMOZOLOMIDETEMOZOLOMIDE
    42737-106TEMOZOLOMIDETEMOZOLOMIDE
    42737-104TEMOZOLOMIDETEMOZOLOMIDE
    42737-102TEMOZOLOMIDETEMOZOLOMIDE
    42737-105TEMOZOLOMIDETEMOZOLOMIDE
    43975-252TEMOZOLOMIDETEMOZOLOMIDE
    43975-256TEMOZOLOMIDETEMOZOLOMIDE

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