69097-988 : Pirfenidone 801 mg Oral Tablet, Coated


NDC: 69097-988
Labeler: Cipla USA Inc.
Product Type: Human Prescription Drug
Drug Name:  Pirfenidone
Dosage Form: Oral Tablet, Coated
Application #: ANDA212708
Rev. Date: 


NDC Package Codes:

  • 69097-988-05: 90 TABLET, COATED IN 1 BOTTLE (69097‑988‑05)
  • 69097-988-93: 270 TABLET, COATED IN 1 BOTTLE (69097‑988‑93)

Active Ingredients:

  • Pirfenidone

Dosage Strength:

  • 801 mg

Pharmaceutical Classes:

  • Pyridone [EPC]
  • Pyridones [CS]

Related Products:

Based on records with the same trade name.
  • 69097-940 Pirfenidone 267 mg Oral Capsule by Cipla USA Inc.
  • 69097-987 Pirfenidone 267 mg Oral Tablet, Coated by Cipla USA Inc.
  • 0480-3610 Pirfenidone 267 mg Oral Tablet, Film Coated by Teva Pharmaceuticals, Inc.
  • 0480-3611 Pirfenidone 801 mg Oral Tablet, Film Coated by Teva Pharmaceuticals, Inc.
  • 0781-2158 Pirfenidone 267 mg Oral Capsule by Sandoz Inc
  • 0781-8085 Pirfenidone 267 mg Oral Tablet, Film Coated by Sandoz Inc
  • 0781-8086 Pirfenidone 801 mg Oral Tablet, Film Coated by Sandoz Inc
  • 0904-7397 Pirfenidone 267 mg Oral Tablet, Film Coated by Major Pharmaceuticals
  • 0904-7398 Pirfenidone 801 mg Oral Tablet, Film Coated by Major Pharmaceuticals
  • 16729-467 Pirfenidone 267 mg Oral Tablet, Film Coated by Accord Healthcare Inc.
  • 16729-468 Pirfenidone 801 mg Oral Tablet, Film Coated by Accord Healthcare Inc.
  • 31722-872 Pirfenidone 267 mg Oral Tablet, Film Coated by Camber Pharmaceuticals, Inc.
  • 31722-873 Pirfenidone 801 mg Oral Tablet, Film Coated by Camber Pharmaceuticals, Inc.
  • 42291-490 Pirfenidone 267 mg Oral Capsule by Avkare
  • 42291-491 Pirfenidone 267 mg Oral Tablet, Film Coated by Avkare
  • 42291-492 Pirfenidone 801 mg Oral Tablet, Film Coated by Avkare
  • 42385-923 Pirfenidone 267 mg Oral Capsule by Laurus Labs Limited
  • 42385-924 Pirfenidone 267 mg Oral Tablet, Film Coated by Laurus Labs Limited
  • 42385-925 Pirfenidone 534 mg Oral Tablet, Film Coated by Laurus Labs Limited
  • 42385-926 Pirfenidone 801 mg Oral Tablet, Film Coated by Laurus Labs Limited
  • 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.