NDC 64980-333

TEMOZOLOMIDE

Temozolomide

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

Product ID64980-333_1c22f9d0-ae27-4e69-8b33-e634071128e8
NDC64980-333
Product TypeHuman Prescription Drug
Proprietary NameTEMOZOLOMIDE
Generic NameTemozolomide
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2017-03-17
Marketing CategoryANDA / ANDA
Application NumberANDA206309
Labeler NameRising Pharmaceuticals, Inc.
Substance NameTEMOZOLOMIDE
Active Ingredient Strength5 mg/1
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 64980-333-05

5 CAPSULE in 1 BOTTLE, PLASTIC (64980-333-05)
Marketing Start Date2017-03-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64980-333-05 [64980033305]

TEMOZOLOMIDE CAPSULE
Marketing CategoryANDA
Application NumberANDA206309
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-17

NDC 64980-333-14 [64980033314]

TEMOZOLOMIDE CAPSULE
Marketing CategoryANDA
Application NumberANDA206309
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-17

Drug Details

Active Ingredients

IngredientStrength
TEMOZOLOMIDE5 mg/1

OpenFDA Data

SPL SET ID:08e25b46-5e48-4027-bdbc-73e85e0ae4a1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 700883
  • 313209
  • 700885
  • 313210
  • 313211
  • 317160
  • UPC Code
  • 0364980336055
  • 0364980335058
  • 0364980337052
  • 0364980338059
  • 0364980334051
  • 0364980333054
  • Pharmacological Class

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