54868-5649 : Rozerem 8 mg Oral Tablet


NDC: 54868-5649
Labeler: Physicians Total Care, Inc.
Product Type: Human Prescription Drug
Drug Name:  Rozerem
Dosage Form: Oral Tablet, Film Coated
Application #: NDA021782
Rev. Date: 


Appearance:


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 Physicians Total Care, 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:

  • 54868-5649-0: 30 TABLET, FILM COATED IN 1 BOTTLE (54868‑5649‑0)

Active Ingredients:

  • Ramelteon

Dosage Strength:

  • 8 mg

Inactive Ingredients:

  • Lactose Monohydrate
  • Starch, Corn
  • Hydroxypropyl Cellulose
  • Magnesium Stearate
  • Hypromellose
  • Copovidone
  • Titanium Dioxide
  • Ferric Oxide Yellow
  • Polyethylene Glycol 8000
  • Shellac
  • Ferrosoferric Oxide

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
  • 63629-3389 Rozerem 8 mg Oral Tablet, Film Coated by Bryant Ranch Prepack
  • 64764-805 Rozerem 8 mg Oral Tablet by Takeda Pharmaceuticals America, Inc.
  • 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

NDC QR Code

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NDC 54868-5649 QR Code

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RDY ROZEREM
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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.