64144-503 : Temozolomide 100 mg Oral Capsule


NDC: 64144-503
Labeler: Idt Australia Limited
Product Type: Human Prescription Drug
Drug Name:  Temozolomide
Dosage Form: Oral Capsule
Application #: ANDA206413
Rev. Date: 


Appearance:


Markings: TEMOZOLAMIDE;100;mg
Shapes:  Capsule
Colors:  Red / White
Size (mm): 20
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 64144-503-01: 1 BOTTLE IN 1 CARTON (64144‑503‑01) > 5 CAPSULE IN 1 BOTTLE
  • 64144-503-02: 1 BOTTLE IN 1 CARTON (64144‑503‑02) > 14 CAPSULE IN 1 BOTTLE

Active Ingredients:

  • Temozolomide

Dosage Strength:

  • 100 mg

Inactive Ingredients:

  • Anhydrous Lactose
  • Sodium Starch Glycolate Type a Potato
  • Silicon Dioxide
  • Stearic Acid
  • Tartaric Acid
  • Gelatin
  • Methylparaben
  • Propylparaben
  • Sodium Lauryl Sulfate
  • Fd&c Red No. 40
  • Titanium Dioxide
  • Water

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 64144-501 Temozolomide 5 mg Oral Capsule by Idt Australia Limited
  • 64144-502 Temozolomide 20 mg Oral Capsule by Idt Australia Limited
  • 64144-504 Temozolomide 140 mg Oral Capsule by Idt Australia Limited
  • 64144-505 Temozolomide 180 mg Oral Capsule by Idt Australia Limited
  • 64144-506 Temozolomide 250 mg Oral Capsule by Idt Australia Limited
  • 0054-0320 Temozolomide 5 mg Oral Capsule by Roxane Laboratories, Inc.
  • 0054-0321 Temozolomide 20 mg Oral Capsule by Roxane Laboratories, Inc.
  • 0054-0322 Temozolomide 100 mg Oral Capsule by Roxane Laboratories, Inc.
  • 0054-0323 Temozolomide 140 mg Oral Capsule by Roxane Laboratories, Inc.
  • 0054-0324 Temozolomide 180 mg Oral Capsule by Roxane Laboratories, Inc.
  • 0054-0325 Temozolomide 250 mg Oral Capsule by Roxane Laboratories, Inc.
  • 0093-7599 Temozolomide 5 mg Oral Capsule by Teva Pharmaceuticals USA Inc
  • 0093-7600 Temozolomide 20 mg Oral Capsule by Teva Pharmaceuticals USA Inc
  • 0093-7601 Temozolomide 100 mg Oral Capsule by Teva Pharmaceuticals USA Inc
  • 0093-7602 Temozolomide 250 mg Oral Capsule by Teva Pharmaceuticals USA Inc
  • 0093-7638 Temozolomide 140 mg Oral Capsule by Teva Pharmaceuticals USA Inc
  • 0093-7639 Temozolomide 180 mg Oral Capsule by Teva Pharmaceuticals USA Inc
  • 0378-5260 Temozolomide 5 mg Oral Capsule by Mylan Pharmaceuticals Inc.
  • 0378-5261 Temozolomide 20 mg Oral Capsule by Mylan Pharmaceuticals Inc.
  • 0378-5262 Temozolomide 100 mg Oral Capsule by Mylan Pharmaceuticals Inc.
  • More related products ...

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.