65162-801 : Temozolomide 5 mg Oral Capsule


NDC: 65162-801
Labeler: Amneal Pharmaceuticals of New York, LLC
Product Type: Human Prescription Drug
Drug Name:  Temozolomide
Dosage Form: Oral Capsule
Application #: ANDA203691
Rev. Date: 


Appearance:


Markings: AMNEAL;801
Shapes:  Capsule
Colors:  White / Green
Size (mm): 16
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:

  • 65162-801-14: 14 CAPSULE IN 1 BOTTLE (65162‑801‑14)
  • 65162-801-51: 5 CAPSULE IN 1 BOTTLE (65162‑801‑51)

Active Ingredients:

  • Temozolomide

Dosage Strength:

  • 5 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Alcohol
  • Anhydrous Lactose
  • Sodium Starch Glycolate Type a Potato
  • Stearic Acid
  • Tartaric Acid
  • Gelatin
  • Titanium Dioxide
  • D&c Yellow No. 10
  • Fd&c Blue No. 1
  • Fd&c Blue No. 2
  • Fd&c Red No. 40
  • Ferrosoferric Oxide
  • Butyl Alcohol
  • Propylene Glycol
  • Shellac
  • Ferric Oxide Yellow

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 65162-802 Temozolomide 20 mg Oral Capsule by Amneal Pharmaceuticals of New York, LLC
  • 65162-803 Temozolomide 100 mg Oral Capsule by Amneal Pharmaceuticals of New York, LLC
  • 65162-804 Temozolomide 140 mg Oral Capsule by Amneal Pharmaceuticals of New York, LLC
  • 65162-805 Temozolomide 180 mg Oral Capsule by Amneal Pharmaceuticals of New York, LLC
  • 65162-806 Temozolomide 250 mg Oral Capsule by Amneal Pharmaceuticals of New York, LLC
  • 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 ...

NDC 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.