NDC 75987-050

Ravicti

Glycerol Phenylbutyrate

Ravicti is a Oral Liquid in the Human Prescription Drug category. It is labeled and distributed by Horizon Therapeutics, Inc.. The primary component is Glycerol Phenylbutyrate.

Product ID75987-050_28732f8f-3f7d-49fc-b0bd-32d2fa73d719
NDC75987-050
Product TypeHuman Prescription Drug
Proprietary NameRavicti
Generic NameGlycerol Phenylbutyrate
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2013-02-28
Marketing CategoryNDA / NDA
Application NumberNDA203284
Labeler NameHorizon Therapeutics, Inc.
Substance NameGLYCEROL PHENYLBUTYRATE
Active Ingredient Strength1 g/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 75987-050-06

1 BOTTLE in 1 CARTON (75987-050-06) > 25 mL in 1 BOTTLE
Marketing Start Date2013-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 75987-050-06 [75987005006]

Ravicti LIQUID
Marketing CategoryNDA
Application NumberNDA203284
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-02-28

NDC 75987-050-07 [75987005007]

Ravicti LIQUID
Marketing CategoryNDA
Application NumberNDA203284
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-02-28

Drug Details

Active Ingredients

IngredientStrength
GLYCEROL PHENYLBUTYRATE1.1 g/mL

OpenFDA Data

SPL SET ID:900e7dc0-9afe-4f50-80de-90567bb78519
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1368453
  • 1368459

    • Trademark Results [Ravicti]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RAVICTI
    RAVICTI
    85167410 4324829 Live/Registered
    HORIZON THERAPEUTICS, LLC
    2010-11-02
    RAVICTI
    RAVICTI
    85143421 not registered Dead/Abandoned
    Hyperion Therapeutics, Inc.
    2010-10-01
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