47335-004 : Carbidopa 31.25 mg / Entacapone 200 mg / Levodopa 125 mg Oral Tablet


NDC: 47335-004
Labeler: Sun Pharma Global Fze
Product Type: Human Prescription Drug
Drug Name:  Carbidopa, Levodopa and Entacapone
Dosage Form: Oral Tablet, Film Coated
Application #: NDA021485
Rev. Date: 


Appearance:


Markings: T1;125
Shapes:  Oval
Colors:  Brown
Size (mm): 14
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:

  • 47335-004-88: 100 TABLET, FILM COATED IN 1 BOTTLE (47335‑004‑88)

Active Ingredients:

  • Carbidopa
  • Levodopa
  • Entacapone

Dosage Strength:

  • 31.25 mg
  • 125 mg
  • 200 mg

Inactive Ingredients:

  • Starch, Corn
  • Croscarmellose Sodium
  • Glycerin
  • Hypromelloses
  • Magnesium Stearate
  • Mannitol
  • Polysorbate 80
  • Povidone
  • Sucrose
  • Ferric Oxide Red
  • Titanium Dioxide

Pharmaceutical Classes:

  • Aromatic Amino Acid [EPC]
  • Amino Acids
  • Aromatic [CS]
  • Catechol O-Methyltransferase Inhibitors [MoA]
  • Catechol-O-Methyltransferase Inhibitor [EPC]

Related Products:

Based on records with the same trade name.
  • 47335-001 Carbidopa 12.5 mg / Entacapone 200 mg / L-dopa 50 mg Oral Tablet by Sun Pharma Global Fze
  • 47335-002 Carbidopa 18.75 mg / Entacapone 200 mg / Levodopa 75 mg Oral Tablet by Sun Pharma Global Fze
  • 47335-003 Carbidopa 25 mg / Entacapone 200 mg / L-dopa 100 mg Oral Tablet by Sun Pharma Global Fze
  • 47335-005 Carbidopa 37.5 mg / Entacapone 200 mg / L-dopa 150 mg Oral Tablet by Sun Pharma Global Fze
  • 47335-006 Carbidopa 50 mg / Entacapone 200 mg / L-dopa 200 mg Oral Tablet by Sun Pharma Global Fze
  • 47335-909 Carbidopa 25 mg / Entacapone 200 mg / L-dopa 100 mg Oral Tablet by Sun Pharma Global Fze
  • 47335-910 Carbidopa 37.5 mg / Entacapone 200 mg / L-dopa 150 mg Oral Tablet by Sun Pharma Global Fze
  • 0378-8300 Carbidopa, Levodopa and Entacapone Oral Tablet, Film Coated by Mylan Pharmaceuticals Inc.
  • 0378-8301 Carbidopa, Levodopa and Entacapone (Carbidopa Anhydrous 18.75 mg / Levodopa 75 mg / Entacapone 200 mg) by Mylan Pharmaceuticals Inc.
  • 0378-8302 Carbidopa, Levodopa and Entacapone (Carbidopa Anhydrous 25 mg / Levodopa 100 mg / Entacapone 200 mg) by Mylan Pharmaceuticals Inc.
  • 0378-8303 Carbidopa, Levodopa and Entacapone (Carbidopa Anhydrous 31.25 mg / Levodopa 125 mg / Entacapone 200 mg) by Mylan Pharmaceuticals Inc.
  • 0378-8304 Carbidopa, Levodopa and Entacapone (Carbidopa Anhydrous 37.5 mg / Levodopa 150 mg / Entacapone 200 mg) by Mylan Pharmaceuticals Inc.
  • 0378-8305 Carbidopa, Levodopa and Entacapone (Carbidopa Anhydrous 50 mg / Levodopa 200 mg / Entacapone 200 mg) by Mylan Pharmaceuticals Inc.
  • 0781-5613 Carbidopa, Levodopa, and Entacapone Oral Tablet, Film Coated by Sandoz Inc
  • 0781-5625 Carbidopa, Levodopa, and Entacapone Oral Tablet, Film Coated by Sandoz Inc
  • 0781-5637 Carbidopa, Levodopa, and Entacapone Oral Tablet, Film Coated by Sandoz Inc
  • 0781-5641 Carbidopa, Levodopa, and Entacapone Oral Tablet, Film Coated by Sandoz Inc
  • 0781-5654 Carbidopa, Levodopa, and Entacapone Oral Tablet, Film Coated by Sandoz Inc
  • 0781-5669 Carbidopa, Levodopa, and Entacapone Oral Tablet, Film Coated by Sandoz Inc
  • 16571-689 Carbidopa, Levodopa and Entacapone Oral Tablet, Film Coated by Rising Pharma Holdings, Inc.
  • More related products ...

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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.