65862-654 : Entacapone 200 mg Oral Tablet, Film Coated


NDC65862-654
Labeler: Aurobindo Pharma Limited
Product Type: Human Prescription Drug
Drug Name:  Entacapone
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA203437
Rev. Date: 


Appearance:


Markings: Y;16
Shapes:  Oval
Colors:  Brown
Size (mm): 17
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:

  • 65862-654-01: 100 TABLET, FILM COATED IN 1 BOTTLE (65862‑654‑01)
  • 65862-654-99: 1000 TABLET, FILM COATED IN 1 BOTTLE (65862‑654‑99)

Active Ingredients:

  • Entacapone

Dosage Strength:

  • 200 mg

Inactive Ingredients:

  • Croscarmellose Sodium
  • Glycerin
  • Hydrogenated Cottonseed Oil
  • Hypromellose 2910 (6 Mpa.s)
  • Ferric Oxide Red
  • Ferric Oxide Yellow
  • Lactose Monohydrate
  • Magnesium Stearate
  • Mannitol
  • Cellulose, Microcrystalline
  • Polysorbate 80
  • Sodium Starch Glycolate Type a Potato
  • Sucrose
  • Titanium Dioxide

Pharmaceutical Classes:

  • Catechol O-Methyltransferase Inhibitors [MoA]
  • Catechol-O-Methyltransferase Inhibitor [EPC]

Related Products:

Based on records with the same trade name.
  • 0179-0166 Entacapone 200 mg Oral Tablet, Film Coated by Kaiser Foundation Hospitals
  • 0378-9080 Entacapone 200 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0781-5578 Entacapone 200 mg Oral Tablet, Film Coated by Sandoz Inc
  • 27241-049 Entacapone 200 mg Oral Tablet by Ajanta Pharma Limited
  • 33342-260 Entacapone 200 mg Oral Tablet by Macleods Pharmaceuticals Limited
  • 42291-268 Entacapone 200 mg Oral Tablet, Film Coated by Avkare, Inc.
  • 43353-996 Entacapone 200 mg Oral Tablet, Film Coated by Aphena Pharma Solutions - Tennessee, LLC
  • 47335-007 Entacapone 200 mg Oral Tablet by Sun Pharma Global Fze
  • 47335-203 Entacapone 200 mg Oral Tablet by Sun Pharma Global Fze
  • 48792-7830 Entacapone 200 mg Oral Tablet, Film Coated by Sunshine Lake Pharma Co., Ltd.
  • 50268-295 Entacapone 200 mg Oral Tablet, Film Coated by Avpak
  • 51079-273 Entacapone 200 mg/1 Oral Tablet, Film Coated by Mylan Institutional Inc.
  • 55648-290 Entacapone 200 mg Oral Tablet by Wockhardt Limited
  • 55648-711 Entacapone 200 mg Oral Tablet by Wockhardt Limited
  • 55648-781 Entacapone 200 mg Oral Tablet by Wockhardt Limited
  • 60687-188 Entacapone 200 mg Oral Tablet, Film Coated by American Health Packaging
  • 64679-290 Entacapone 200 mg Oral Tablet by Wockhardt USA LLC.
  • 64679-711 Entacapone 200 mg Oral Tablet by Wockhardt USA LLC.
  • 64679-781 Entacapone 200 mg Oral Tablet by Wockhardt USA LLC.
  • 69189-0355 Entacapone 200 mg Oral Tablet, Film Coated by Avera Mckennan Hospital
  • More related products ...

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