54868-5348 : Temodar 5 mg Oral Capsule


NDC54868-5348
Labeler: Physicians Total Care, Inc.
Product Type: Human Prescription Drug
Drug Name:  Temodar
Dosage Form: Oral Capsule
Application #: NDA021029
Rev. Date: 


Appearance:


Markings: TEMODAR;5;mg
Shapes:  Capsule
Colors:  Green / White
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:

  • 54868-5348-1: 5 CAPSULE IN 1 BOTTLE (54868‑5348‑1)

Active Ingredients:

  • Temozolomide

Dosage Strength:

  • 5 mg

Inactive Ingredients:

  • Anhydrous Lactose
  • Silicon Dioxide
  • Sodium Starch Glycolate Type a Potato
  • Tartaric Acid
  • Stearic Acid
  • Shellac
  • Alcohol
  • Isopropyl Alcohol
  • Butyl Alcohol
  • Propylene Glycol
  • Water
  • Ammonia
  • Potassium Hydroxide
  • Ferric Oxide Red
  • Gelatin
  • Titanium Dioxide
  • Ferric Oxide Yellow
  • Sodium Lauryl Sulfate
  • Fd&c Blue No. 2

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 54868-4142 Temodar 20 mg Oral Capsule by Physicians Total Care, Inc.
  • 54868-5350 Temodar 100 mg Oral Capsule by Physicians Total Care, Inc.
  • 54868-5354 Temodar 250 mg Oral Capsule by Physicians Total Care, Inc.
  • 54868-5980 Temodar 180 mg Oral Capsule by Physicians Total Care, Inc.
  • 0085-1366 Temodar 100 mg Oral Capsule by Merck Sharp & Dohme Corp.
  • 0085-1381 Temodar 2.5 mg/ml Intravenous Injection, Powder, Lyophilized, for Solution by Merck Sharp & Dohme Corp.
  • 0085-1417 Temodar 250 mg Oral Capsule by Merck Sharp & Dohme Corp.
  • 0085-1425 Temodar 140 mg Oral Capsule by Merck Sharp & Dohme Corp.
  • 0085-1430 Temodar 180 mg Oral Capsule by Merck Sharp & Dohme Corp.
  • 0085-1519 Temodar 20 mg Oral Capsule by Merck Sharp & Dohme Corp.
  • 0085-3004 Temodar 5 mg Oral Capsule by Merck Sharp & Dohme Corp.

NDC QR Code

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