52609-0001 : Alkeran 2 mg Oral Tablet

Labeler: Apo-pharma USA, Inc
Product Type: Human Prescription Drug
Drug Name:  Alkeran
Dosage Form: Oral Tablet, Film Coated
Application #: NDA014691
Rev. Date: 


Markings: GX;EH3;A
Shapes:  Round
Colors:  White
Size (mm): 7
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.

GX EH3 A: (52609-0001) Alkeran 2 mg Oral Tablet by Apo-pharma USA, 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:

  • 52609-0001-5: 50 TABLET, FILM COATED IN 1 BOTTLE (52609‑0001‑5)

Active Ingredients:

  • Melphalan

Dosage Strength:

  • 2 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Crospovidone
  • Hypromelloses
  • Polyethylene Glycol 400
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Titanium Dioxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 52609-3001 Alkeran Kit by Apo-pharma USA, Inc
  • 63379-018 Alkeran Kit by Glaxo Operations Uk Ltd


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