54482-053 : Matulane 50 mg Oral Capsule

Labeler: Sigma-tau Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Matulane
Dosage Form: Oral Capsule
Application #: NDA016785
Rev. Date: 


Markings: MATULANE;sigma;tau
Shapes:  Capsule
Colors:  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.

MATULANE sigma tau: (54482-053) Matulane 50 mg Oral Capsule by Sigma-tau Pharmaceuticals, Inc.
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 54482-053-01: 100 CAPSULE IN 1 BOTTLE (54482‑053‑01)

Active Ingredients:

  • Procarbazine Hydrochloride

Dosage Strength:

  • 50 mg

Inactive Ingredients:

  • Starch, Corn
  • Mannitol
  • Talc
  • Gelatin
  • Methylparaben
  • Propylparaben
  • Potassium Sorbate
  • Titanium Dioxide
  • Fd&c Yellow No. 6
  • D&c Yellow No. 10

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 54482-054 Matulane 50 mg Oral Capsule by Leadiant Biosciences, Inc.


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