69097-393 : Deferasirox 360 mg Oral Tablet, Coated


NDC: 69097-393
Labeler: Cipla USA Inc.
Product Type: Human Prescription Drug
Drug Name:  Deferasirox
Dosage Form: Oral Tablet, Coated
Application #: ANDA211852
Rev. Date: 


Appearance:


Markings: C393
Shapes:  Oval
Colors:  Pink
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:

  • 69097-393-02: 30 TABLET, COATED IN 1 BOTTLE (69097‑393‑02)
  • 69097-393-20: 5 BLISTER PACK IN 1 CARTON (69097‑393‑20) > 10 TABLET, COATED IN 1 BLISTER PACK (69097‑393‑19)

Active Ingredients:

  • Deferasirox

Dosage Strength:

  • 360 mg

Inactive Ingredients:

  • Lactose Monohydrate
  • Magnesium Stearate
  • Microcrystalline Cellulose
  • Poloxamer 188
  • Povidone K30
  • Ferric Oxide Red
  • Talc
  • Titanium Dioxide
  • Polyethylene Glycol 8000
  • Hypromellose 2910 (6 Mpa.s)
  • Crospovidone (15 Mpa.s At 5%) /

Pharmaceutical Classes:

  • Iron Chelating Activity [MoA]
  • Iron Chelator [EPC]
  • Cytochrome P450 3A4 Inducers [MoA]
  • Cytochrome P450 2C8 Inhibitors [MoA]
  • Cytochrome P450 1A2 Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 69097-391 Deferasirox 90 mg Oral Tablet, Coated by Cipla USA Inc.
  • 69097-392 Deferasirox 180 mg Oral Tablet, Coated by Cipla USA Inc.
  • 69097-550 Deferasirox 90 mg Oral Granule by Cipla USA Inc.
  • 69097-560 Deferasirox 180 mg Oral Granule by Cipla USA Inc.
  • 69097-570 Deferasirox 360 mg Oral Granule by Cipla USA Inc.
  • 0093-3515 Deferasirox 360 mg Oral Tablet by Teva Pharmaceuticals USA, Inc.
  • 0093-3516 Deferasirox 180 mg Oral Tablet, Film Coated by Teva Pharmaceuticals USA, Inc.
  • 0093-3517 Deferasirox 90 mg Oral Tablet by Teva Pharmaceuticals USA, Inc.
  • 0591-3853 Deferasirox 180 mg Oral Tablet, Film Coated by Actavis Pharma, Inc.
  • 0591-4730 Deferasirox 90 mg Oral Granule by Actavis Pharma, Inc.
  • 0591-4735 Deferasirox 180 mg Oral Granule by Actavis Pharma, Inc.
  • 0591-4740 Deferasirox 360 mg Oral Granule by Actavis Pharma, Inc.
  • 16714-993 Deferasirox 90 mg Oral Tablet, Film Coated by Northstar Rx LLC.
  • 16714-994 Deferasirox 180 mg Oral Tablet, Film Coated by Northstar Rx LLC.
  • 16714-995 Deferasirox 360 mg Oral Tablet, Film Coated by Northstar Rx LLC.
  • 31722-011 Deferasirox 90 mg Oral Tablet, Film Coated by Camber Pharmaceuticals, Inc.
  • 31722-012 Deferasirox 180 mg Oral Tablet, Film Coated by Camber Pharmaceuticals, Inc.
  • 31722-013 Deferasirox 360 mg Oral Tablet, Film Coated by Camber Pharmaceuticals, Inc.
  • 31722-029 Deferasirox 90 mg Oral Granule by Camber Pharmaceuticals, Inc.
  • 31722-030 Deferasirox 180 mg Oral Granule by Camber Pharmaceuticals, Inc.
  • More related products ...

NDC 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.