64764-805 : Rozerem 8 mg Oral Tablet

Labeler: Takeda Pharmaceuticals America, Inc.
Product Type: Human Prescription Drug
Drug Name:  Rozerem
Dosage Form: Oral Tablet, Film Coated
Application #: NDA021782
Rev. Date: 


Markings: TAK;RAM;8
Shapes:  Round
Colors:  Orange
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.

TAK RAM 8: (64764-805) Rozerem 8 mg Oral Tablet by Takeda Pharmaceuticals America, 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:

  • 64764-805-10: 100 TABLET, FILM COATED IN 1 BOTTLE (64764‑805‑10)
  • 64764-805-22: 6 CARTON IN 1 TRAY (64764‑805‑22) > 1 BLISTER PACK IN 1 CARTON > 2 TABLET, FILM COATED IN 1 BLISTER PACK
  • 64764-805-30: 30 TABLET, FILM COATED IN 1 BOTTLE (64764‑805‑30)

Active Ingredients:

  • Ramelteon

Dosage Strength:

  • 8 mg

Pharmaceutical Classes:

  • Melatonin Receptor Agonist [EPC]
  • Melatonin Receptor Agonists [MoA]

Related Products:

Based on records with the same trade name.
  • 21695-183 Rozerem 8 mg Oral Tablet by Rebel Distributors Corp
  • 35356-092 Ramelteon 8 mg Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 54868-5649 Rozerem 8 mg Oral Tablet by Physicians Total Care, Inc.
  • 63629-3389 Rozerem 8 mg Oral Tablet, Film Coated by Bryant Ranch Prepack
  • 68151-4881 Rozerem 8 mg Oral Tablet, Film Coated by Carilion Materials Management
  • 69189-0805 Rozerem 8 mg Oral Tablet, Film Coated by Avera Mckennan Hospital


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