52125-727 : Naltrexone 50 mg Oral Tablet


NDC: 52125-727
Labeler: Remedyrepack Inc.
Product Type: Human Prescription Drug
Drug Name:  Naltrexone Hydrochloride
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA091205
Rev. Date: 


Appearance:


Markings: 50
Shapes:  Oval
Colors:  Yellow
Size (mm): 13
Segments: * 2

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

NDC Package Codes:

  • 52125-727-02: 30 TABLET, FILM COATED IN 1 BOTTLE (52125‑727‑02)

Active Ingredients:

  • Naltrexone Hydrochloride

Dosage Strength:

  • 50 mg

Inactive Ingredients:

  • Cellulose, Microcrystalline
  • Polysorbate 80
  • Ferric Oxide Red
  • Ferric Oxide Yellow
  • Polyethylene Glycol 400
  • Silicon Dioxide
  • Crospovidone
  • Hypromelloses
  • Magnesium Stearate
  • Lactose Monohydrate
  • Titanium Dioxide

Pharmaceutical Classes:

  • Opioid Antagonist [EPC]
  • Opioid Antagonists [MoA]

Related Products:

Based on records with the same trade name.
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  • 47335-326 Naltrexone 50 mg Oral Tablet by Sun Pharma Global Fze
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  • 50436-0105 Naltrexone 50 mg Oral Tablet by Unit Dose Services
  • 51224-206 Naltrexone Hydrochloride 50 mg/1 Oral Tablet, Film Coated by Tagi Pharma Inc.
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NDC QR Code

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NDC 52125-727 QR Code

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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.