59630-580 : Osphena 60 mg Oral Tablet


NDC: 59630-580
Labeler: Shionogi Inc.
Product Type: Human Prescription Drug
Drug Name:  Osphena
Dosage Form: Oral Tablet, Film Coated
Application #: NDA203505
Rev. Date: 


Appearance:


Markings: 60
Shapes:  Oval
Colors:  White
Size (mm): 12
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:

  • 59630-580-00: 36 CARTON IN 1 CONTAINER (59630‑580‑00) > 600 BLISTER PACK IN 1 CARTON > 15 TABLET, FILM COATED IN 1 BLISTER PACK
  • 59630-580-10: 100 TABLET, FILM COATED IN 1 BOTTLE (59630‑580‑10)
  • 59630-580-18: 1 BLISTER PACK IN 1 PACKAGE (59630‑580‑18) > 15 TABLET, FILM COATED IN 1 BLISTER PACK
  • 59630-580-30: 2 BLISTER PACK IN 1 PACKAGE (59630‑580‑30) > 15 TABLET, FILM COATED IN 1 BLISTER PACK
  • 59630-580-50: 36 CARTON IN 1 CONTAINER (59630‑580‑50) > 1250 BLISTER PACK IN 1 CARTON > 5 TABLET, FILM COATED IN 1 BLISTER PACK
  • 59630-580-55: 1 BLISTER PACK IN 1 PACKAGE (59630‑580‑55) > 5 TABLET, FILM COATED IN 1 BLISTER PACK
  • 59630-580-90: 90 TABLET, FILM COATED IN 1 BOTTLE (59630‑580‑90)

Active Ingredients:

  • Ospemifene

Dosage Strength:

  • 60 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Hypromelloses
  • Lactose Monohydrate
  • Magnesium Stearate
  • Mannitol
  • Cellulose, Microcrystalline
  • Polyethylene Glycols
  • Povidones
  • Titanium Dioxide
  • Triacetin
  • Starch, Corn
  • Sodium Starch Glycolate Type a Potato

Pharmaceutical Classes:

  • Estrogen Agonist/Antagonist [EPC]
  • Selective Estrogen Receptor Modulators [MoA]

Related Products:

Based on records with the same trade name.
  • 55494-580 Osphena 60 mg Oral Tablet, Film Coated by Duchesnay USA, Inc.

NDC QR Code

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NDC 59630-580 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.