0054-0320 : Temozolomide 5 mg Oral Capsule


NDC: 0054-0320
Labeler: Roxane Laboratories, Inc.
Product Type: Human Prescription Drug
Drug Name:  Temozolomide
Dosage Form: Oral Capsule
Application #: ANDA202606
Rev. Date: 


Appearance:


Markings: 54688
Shapes:  Capsule
Colors:  Green / White
Size (mm): 12
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.

Active Ingredients:

  • Temozolomide

Dosage Strength:

  • 5 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Anhydrous Lactose
  • Magnesium Stearate
  • Sodium Starch Glycolate Type a Potato
  • Tartaric Acid
  • Gelatin
  • Titanium Dioxide
  • Fd&c Blue No. 1
  • Fd&c Yellow No. 5
  • Fd&c Yellow No. 6
  • Ferrosoferric Oxide
  • Ferric Oxide Red
  • Alcohol
  • Ferric Oxide Yellow
  • Polyethylene Glycols
  • Shellac
  • Isobutyl Alcohol

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 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.
  • 0378-5263 Temozolomide 140 mg Oral Capsule by Mylan Pharmaceuticals Inc.
  • 0378-5264 Temozolomide 180 mg Oral Capsule by Mylan Pharmaceuticals Inc.
  • 0378-5265 Temozolomide 250 mg Oral Capsule by Mylan Pharmaceuticals Inc.
  • 0527-1777 Temozolomide 5 mg Oral Capsule by Lannett Company, Inc.
  • 0527-1778 Temozolomide 20 mg Oral Capsule by Lannett Company, Inc.
  • 0527-1779 Temozolomide 100 mg Oral Capsule by Lannett Company, Inc.
  • More related products ...

NDC QR Code

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NDC 0054-0320 QR Code

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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.