0074-0039 : Orilissa 200 mg Oral Tablet, Film Coated


NDC0074-0039
Labeler: Abbvie Inc.
Product Type: Human Prescription Drug
Drug Name:  Orilissa
Dosage Form: Oral Tablet, Film Coated
Application #: NDA210450
Rev. Date: 


Appearance:


Markings: EL;200
Shapes:  Oval
Colors:  Orange
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:

  • 0074-0039-01: 1 BLISTER PACK IN 1 CARTON (0074‑0039‑01) > 14 TABLET, FILM COATED IN 1 BLISTER PACK
  • 0074-0039-14: 1 BLISTER PACK IN 1 CARTON (0074‑0039‑14) > 14 TABLET, FILM COATED IN 1 BLISTER PACK
  • 0074-0039-56: 4 BLISTER PACK IN 1 CARTON (0074‑0039‑56) > 14 TABLET, FILM COATED IN 1 BLISTER PACK

Active Ingredients:

  • Elagolix Sodium

Dosage Strength:

  • 200 mg

Inactive Ingredients:

  • Mannitol
  • Sodium Carbonate Monohydrate
  • Starch, Corn
  • Povidone, Unspecified
  • Magnesium Stearate
  • Polyvinyl Alcohol, Unspecified
  • Titanium Dioxide
  • Polyethylene Glycol, Unspecified
  • Talc
  • Ferric Oxide Red /

Pharmaceutical Classes:

  • Cytochrome P450 2C19 Inhibitors [MoA]
  • Cytochrome P450 3A Inducers [MoA]
  • Decreased GnRH Secretion [PE]
  • Gonadotropin Releasing Hormone Receptor Antagonist [EPC]
  • Gonadotropin Releasing Hormone Receptor Antagonists [MoA]
  • P-Glycoprotein Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 0074-0038 Orilissa 150 mg Oral Tablet, Film Coated by Abbvie Inc.

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.