50242-123 : Esbriet 801 mg Oral Tablet, Coated


NDC50242-123
Labeler: Genentech, Inc.
Product Type: Human Prescription Drug
Drug Name:  Esbriet
Dosage Form: Oral Tablet, Coated
Application #: NDA208780
Rev. Date: 


Appearance:


Markings: PFD
Shapes:  Oval
Colors:  Brown
Size (mm): 20
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:

  • 50242-123-01: 1 BOTTLE, PLASTIC IN 1 CARTON (50242‑123‑01) > 90 TABLET, COATED IN 1 BOTTLE, PLASTIC

Active Ingredients:

  • Pirfenidone

Dosage Strength:

  • 801 mg

Inactive Ingredients:

  • Microcrystalline Cellulose
  • Silicon Dioxide
  • Povidone K30
  • Croscarmellose Sodium
  • Magnesium Stearate
  • Polyvinyl Alcohol, Unspecified
  • Titanium Dioxide
  • Polyethylene Glycol 3350
  • Talc
  • Ferric Oxide Red
  • Ferrosoferric Oxide

Pharmaceutical Classes:

  • Pyridone [EPC]
  • Pyridones [Chemical/Ingredient]

Related Products:

Based on records with the same trade name.
  • 50242-121 Esbriet 267 mg Oral Capsule by Genentech, Inc.
  • 50242-122 Esbriet 267 mg Oral Tablet, Coated by Genentech, Inc.
  • 64116-121 Esbriet 267 mg Oral Capsule by Intermune, Inc.

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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.