0378-2005 : Paroxetine (As Paroxetine Hydrochloride) 37.5 mg Extended Release Tablet


NDC: 0378-2005
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Paroxetine Hydrochloride
Dosage Form: Oral Tablet, Film Coated, Extended Release
Application #: ANDA091427
Rev. Date: 


Appearance:


Markings: M;P5
Shapes:  Round
Colors:  Orange
Size (mm): 8
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.

M P5: (0378-2005) Paroxetine (As Paroxetine Hydrochloride) 37.5 mg Extended Release Tablet by Mylan Pharmaceuticals 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:

  • 0378-2005-01: 100 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (0378‑2005‑01)
  • 0378-2005-05: 500 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (0378‑2005‑05)
  • 0378-2005-93: 30 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (0378‑2005‑93)

Active Ingredients:

  • Paroxetine Hydrochloride Hemihydrate

Dosage Strength:

  • 37.5 mg

Inactive Ingredients:

  • Ferrosoferric Oxide
  • Silicon Dioxide
  • D&c Red No. 30
  • Fd&c Yellow No. 6
  • Hydroxypropyl Cellulose (Type H)
  • Hypromelloses
  • Lactose Monohydrate
  • Lecithin, Soybean
  • Magnesium Stearate
  • Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
  • Cellulose, Microcrystalline
  • Polydextrose
  • Polyethylene Glycols
  • Polysorbate 80
  • Propylene Glycol
  • Sodium Alginate
  • Sodium Hydroxide
  • Talc
  • Titanium Dioxide
  • Triacetin
  • Triethyl Citrate

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 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.
  • 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.
  • 54868-1819 Paroxetine (As Paroxetine Hydrochloride) 25 mg Extended Release Tablet by Physicians Total Care, Inc.
  • 54868-6178 Paroxetine (As Paroxetine Hydrochloride) 12.5 mg Extended Release Tablet by Physicians Total Care, Inc.
  • 58517-160 Paroxetine 20 mg (As Paroxetine Hydrochloride 22.76 mg ) Oral Tablet by New Horizon Rx Group, LLC
  • 60505-1316 Paroxetine Hydrochloride 12.5 mg Oral Tablet, Film Coated, Extended Release by Apotex Corp
  • 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
  • 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.