60505-4377 : Paxil 12.5 mg Oral Tablet, Film Coated, Extended Release


NDC: 60505-4377
Labeler: Apotex Corp
Product Type: Human Prescription Drug
Drug Name:  Paxil CR
Dosage Form: Oral Tablet, Film Coated, Extended Release
Application #: NDA020936
Rev. Date: 


Appearance:


Markings: 12;5
Shapes:  Round
Colors:  Yellow
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.

NDC Package Codes:

  • 60505-4377-3: 30 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (60505‑4377‑3)

Active Ingredients:

  • Paroxetine Hydrochloride Hemihydrate

Dosage Strength:

  • 12.5 mg

Inactive Ingredients:

  • Hypromellose, Unspecified
  • Povidone K30
  • Lactose Monohydrate
  • Magnesium Stearate
  • Silicon Dioxide
  • Glyceryl Dibehenate
  • Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
  • Sodium Lauryl Sulfate
  • Polysorbate 80
  • Talc
  • Triethyl Citrate
  • Titanium Dioxide
  • Polyethylene Glycol 10000
  • D&c Yellow No. 10
  • Fd&c Yellow No. 6
  • Ferric Oxide Yellow /

Pharmaceutical Classes:

  • Serotonin Reuptake Inhibitor [EPC]
  • Serotonin Uptake Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 60505-4378 Paxil 25 mg Oral Tablet, Film Coated, Extended Release by Apotex Corp
  • 60505-4379 Paxil 37.5 mg Oral Tablet, Film Coated, Extended Release by Apotex Corp
  • 71335-0572 Paxil 25 mg Oral Tablet, Film Coated, Extended Release by Bryant Ranch Prepack

NDC QR Code

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NDC 60505-4377 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.