60505-1316 : Paroxetine Hydrochloride 12.5 mg Oral Tablet, Film Coated, Extended Release


NDC: 60505-1316
Labeler: Apotex Corp
Product Type: Human Prescription Drug
Drug Name:  Paroxetine Hydrochloride
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:

  • 60505-1316-3: 30 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (60505‑1316‑3)

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.
  • 60505-1317 Paroxetine Hydrochloride 25 mg Oral Tablet, Film Coated, Extended Release by Apotex Corp
  • 60505-1318 Paroxetine Hydrochloride 37.5 mg Oral Tablet, Film Coated, Extended Release by Apotex Corp
  • 60505-3673 Paroxetine (As Paroxetine Hydrochloride) 12.5 mg Extended Release Tablet by Apotex Corp
  • 60505-3674 Paroxetine (As Paroxetine Hydrochloride) 25 mg Extended Release Tablet by Apotex Corp
  • 60505-3675 Paroxetine (As Paroxetine Hydrochloride) 37.5 mg Extended Release Tablet by Apotex Corp
  • 0378-2003 Paroxetine (As Paroxetine Hydrochloride) 12.5 mg Extended Release Tablet by Mylan Pharmaceuticals Inc.
  • 0378-2004 Paroxetine (As Paroxetine Hydrochloride) 25 mg Extended Release Tablet by Mylan Pharmaceuticals Inc.
  • 0378-2005 Paroxetine (As Paroxetine Hydrochloride) 37.5 mg Extended Release Tablet by Mylan Pharmaceuticals Inc.
  • 42291-579 Paroxetine Hydrochloride 12.5 mg Oral Tablet, Film Coated, Extended Release by Avkare, Inc.
  • 42291-580 Paroxetine Hydrochloride 25 mg Oral Tablet, Film Coated, Extended Release by Avkare, Inc.
  • 42291-581 Paroxetine Hydrochloride 37.5 mg Oral Tablet, Film Coated, Extended Release by Avkare, Inc.
  • 49349-255 Paroxetine 20 mg (As Paroxetine Hydrochloride 22.76 mg ) Oral Tablet by Remedyrepack Inc.
  • 49349-285 Paroxetine 40 mg (As Paroxetine Hydrochloride 44.44 mg) Oral Tablet by Remedyrepack Inc.
  • 49349-305 Paroxetine 30 mg (As Paroxetine Hydrochloride 34.14 mg) Oral Tablet by Remedyrepack Inc.
  • 49349-308 Paroxetine 10 mg (As Paroxetine Hydrochloride 11.38 mg) Oral Tablet by Remedyrepack Inc.
  • 49349-364 Paroxetine 20 mg (As Paroxetine Hydrochloride 22.76 mg ) Oral Tablet by Remedyrepack Inc.
  • 49349-407 Paroxetine 20 mg (As Paroxetine Hydrochloride 22.76 mg ) Oral Tablet by Remedyrepack Inc.
  • 49349-610 Paroxetine 10 mg (As Paroxetine Hydrochloride 11.38 mg) Oral Tablet by Remedyrepack Inc.
  • 51079-824 Paroxetine (As Paroxetine Hydrochloride) 12.5 mg Extended Release Tablet by Mylan Institutional Inc.
  • 51079-825 Paroxetine (As Paroxetine Hydrochloride) 25 mg Extended Release Tablet by Mylan Institutional Inc.
  • More related products ...

NDC 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.