Home RxNorm 1368459 glycerol phenylbutyrate 1100 MG/ML Oral Solution [Ravicti] Drug identity information. FDA.report links public drug records from RxNav, DailyMed, FDA NDC, Drugs@FDA, and related public sources where available. This page is informational only and is not medical, prescribing, or regulatory advice.
RxCUI 1368459
RxNorm name glycerol phenylbutyrate 1100 MG/ML Oral Solution [Ravicti]
Display name RAVICTI (Oral Liquid)
Full name glycerol phenylbutyrate 1100 MG/ML Oral Solution [Ravicti]
Term type SBD
Status Active
Strength 1,100 mg/ml
Dose form Sol
Route Oral Liquid
Updated 2026-10-15 14:48:05 RxNorm Status History#
Status Active
Source RXNORM
Current YES
Release start 032013
Active start 032013
Multiple ingredient NO
Branded YES Ingredients And Strength# Ingredient, Strength, Base table Ingredient Strength Base Basis of strength glycerol phenylbutyrate 1100 MG / 1 ML glycerol phenylbutyrate glycerol phenylbutyrate
Derived Ingredient Concepts# FDA NDC Products And Packages# Package NDC, Product NDC, Name table Package NDC Product NDC Name Labeler Application 75987-050-06 75987-050 Ravicti glycerol phenylbutyrate Horizon Therapeutics USA, Inc. NDA203284 75987-050-07 75987-050 Ravicti glycerol phenylbutyrate Horizon Therapeutics USA, Inc. NDA203284
Drugs@FDA Applications# Application, NDC, Name table Application NDC Name Marketing category Labeler NDA203284 75987-050 Ravicti glycerol phenylbutyrate NDA Horizon Therapeutics USA, Inc.
RxNav Current And Historical NDCs# RxNav current and historical NDC rows page 1 of 1 · 4 matching rows.
NDC11, Source, Active table NDC11 Source Active 75987005006 rxnav_ndcs yes 75987005007 rxnav_ndcs yes 76325010004 rxnav_historical 76325010025 rxnav_historical
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No records found.
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Matched openFDA labels page 1 of 1 · 1 matching rows.
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Set ID, RxNorm mappings, Terms table Set ID RxNorm mappings Terms SPL version Label Effective 900e7dc0-9afe-4f50-80de-90567bb78519 RAVICTI 1.1 GM in 1 mL Oral Solution [PSN] · glycerol phenylbutyrate 1100 MG/ML Oral Solution [Ravicti] [SBD] · Ravicti 1100 MG/ML Oral Solution [SY] 3 13 These highlights do not include all the information needed to use RAVICTI safely and effectively. See full prescribing information for RAVICTI. RAVICTI ® (glycerol phenylbutyrate) oral liquid Initial U.S. Approval: 1996 20251029
Recently Linked DailyMed Labels# Set ID, Title, Manufacturer table Set ID Title Manufacturer Effective 900e7dc0-9afe-4f50-80de-90567bb78519 These highlights do not include all the information needed to use RAVICTI safely and effectively. See full prescribing information for RAVICTI. RAVICTI ® (glycerol phenylbutyrate) oral liquid Initial U.S. Approval: 1996 Horizon Therapeutics USA, Inc. 20251029 679358ec-a0b9-4a6f-9f01-5811af66b917 National Council for Prescription Drug Programs 20130303 d6f90cf0-536e-4359-b750-33253a5f3110 National Council for Prescription Drug Programs 20130303
Properties# Category, Property, Value table Category Property Value ATTRIBUTES AVAILABLE_STRENGTH 1100 MG/ML (expressed as glycerol phenylbutyrate) ATTRIBUTES GENERAL_CARDINALITY SINGLE ATTRIBUTES HUMAN_DRUG US ATTRIBUTES RXNAV_HUMAN_DRUG US ATTRIBUTES SCHEDULE 0 CODES NDA NDA203284 NAMES Prescribable Synonym RAVICTI 1.1 GM in 1 mL Oral Solution SOURCES Source Gold Standard Alchemy SOURCES Source Metathesaurus FDA Structured Product Labels SOURCES Source Micromedex RED BOOK SOURCES Source Multum MediSource Lexicon