0115-1385 : Ezetimibe and Simvastatin Oral Tablet, Film Coated


NDC0115-1385
Labeler: Impax Generics
Product Type: Human Prescription Drug
Drug Name:  Ezetimibe and Simvastatin
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA201890
Rev. Date: 


Appearance:


Markings: P61;P61
Shapes:  Oval
Colors:  Pink
Size (mm): 15
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:

  • 0115-1385-03: 1000 TABLET, FILM COATED IN 1 BOTTLE (0115‑1385‑03)
  • 0115-1385-08: 30 TABLET, FILM COATED IN 1 BOTTLE (0115‑1385‑08)
  • 0115-1385-10: 90 TABLET, FILM COATED IN 1 BOTTLE (0115‑1385‑10)

Active Ingredients:

  • Ezetimibe
  • Simvastatin

Dosage Strength:

  • 10 mg
  • 10 mg

Inactive Ingredients:

  • Ascorbic Acid
  • Butylated Hydroxyanisole
  • Anhydrous Citric Acid
  • Starch, Corn
  • Croscarmellose Sodium
  • Hypromellose 2910 (6 Mpa.s)
  • Lactose Monohydrate
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polyethylene Glycol 3350
  • Talc
  • Titanium Dioxide
  • Fd&c Red No. 40
  • Fd&c Blue No. 2

Pharmaceutical Classes:

  • Decreased Cholesterol Absorption [PE]
  • Dietary Cholesterol Absorption Inhibitor [EPC]
  • HMG-CoA Reductase Inhibitor [EPC]
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 0115-1386 Ezetimibe and Simvastatin Oral Tablet, Film Coated by Impax Generics
  • 0115-1387 Ezetimibe and Simvastatin Oral Tablet, Film Coated by Impax Generics
  • 0115-1388 Ezetimibe and Simvastatin Oral Tablet, Film Coated by Impax Generics
  • 16714-778 Ezetimibe and Simvastatin Oral Tablet by Northstar Rx LLC
  • 16714-779 Ezetimibe and Simvastatin Oral Tablet by Northstar Rx LLC
  • 16714-780 Ezetimibe and Simvastatin Oral Tablet by Northstar Rx LLC
  • 16714-781 Ezetimibe and Simvastatin Oral Tablet by Northstar Rx LLC
  • 42291-078 Ezetimibe and Simvastatin Oral Tablet by Avkare
  • 42291-079 Ezetimibe and Simvastatin Oral Tablet by Avkare
  • 42291-080 Ezetimibe and Simvastatin Oral Tablet by Avkare
  • 42291-081 Ezetimibe and Simvastatin Oral Tablet by Avkare
  • 43598-583 Ezetimibe and Simvastatin Oral Tablet by Dr.reddys Laboratories Inc
  • 43598-584 Ezetimibe and Simvastatin Oral Tablet by Dr.reddys Laboratories Inc
  • 43598-585 Ezetimibe and Simvastatin Oral Tablet by Dr.reddys Laboratories Inc
  • 43598-586 Ezetimibe and Simvastatin Oral Tablet by Dr.reddys Laboratories Inc
  • 43598-742 Ezetimibe and Simvastatin Oral Tablet by Dr.reddys Laboratories Inc
  • 43598-743 Ezetimibe and Simvastatin Oral Tablet by Dr.reddys Laboratories Inc
  • 43598-744 Ezetimibe and Simvastatin Oral Tablet by Dr.reddys Laboratories Inc
  • 43598-745 Ezetimibe and Simvastatin Oral Tablet by Dr.reddys Laboratories Inc
  • 45963-565 Ezetimibe and Simvastatin Oral Tablet by Actavis Pharma, Inc.
  • More related products ...

NDC QR Code

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NDC 0115-1385 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.