FDA.reportPublic FDA data

GLYCEROL PHENYLBUTYRATE - Food and Drug Administration

Manufacturer
Food and Drug Administration
Effective date
2017-07-11
Label type
Indexing - product concept
Version
1
Source
full-release
Hydrated at
2026-06-05 00:17:05

Label at a glance#

ProductGLYCEROL PHENYLBUTYRATE
Active ingredientGLYCEROL PHENYLBUTYRATE

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCEROL PHENYLBUTYRATEZH6F1VCV7BACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glycerol PhenylbutyrateGLYCEROL PHENYLBUTYRATE ORALCamber Pharmaceuticals, Inc.d3b52ded-b305-445c-b943-ef0fb2dedd2b2026-08-24Warnings, Adverse reactionsName fallback
brand name: Glycerol Phenylbutyrate
Glycerol PhenylbutyrateGLYCEROL PHENYLBUTYRATENavinta LLC15c4da9f-f5e0-4628-b55f-3730be3e1c392026-06-23Warnings, Adverse reactionsName fallback
brand name: Glycerol Phenylbutyrate
generic name: GLYCEROL PHENYLBUTYRATE
Glycerol phenylbutyrateGLYCEROL PHENYLBUTYRATENovadoz Pharmaceuticals LLCb4dc2c81-3b30-4bb8-af7d-4d093981c3862026-04-16Warnings, Adverse reactionsName fallback
brand name: Glycerol phenylbutyrate
generic name: GLYCEROL PHENYLBUTYRATE
Glycerol PhenylbutyrateGLYCEROL PHENYLBUTYRATEAurobindo Pharma Limited11981aec-dbf1-4906-acfd-3c10708fe0a62026-04-09Warnings, Adverse reactionsName fallback
brand name: Glycerol Phenylbutyrate
generic name: GLYCEROL PHENYLBUTYRATE
Glycerol PhenylbutyrateGLYCEROL PHENYLBUTYRATEZydus Pharmaceuticals USA Inc.c094cb63-3aa0-4564-9c53-7e78f2a563672026-04-01Warnings, Adverse reactionsName fallback
brand name: Glycerol Phenylbutyrate
generic name: GLYCEROL PHENYLBUTYRATE
RavictiGLYCEROL PHENYLBUTYRATEHorizon Therapeutics USA, Inc.900e7dc0-9afe-4f50-80de-90567bb785192025-10-29Warnings, Adverse reactionsName fallback
generic name: GLYCEROL PHENYLBUTYRATE
Glycerol PhenylbutyrateGLYCEROL PHENYLBUTYRATE ORALPar Health USA, LLCe78f2dfd-fb39-4e4b-a639-64591d282ca62025-10-09Warnings, Adverse reactionsName fallback
brand name: Glycerol Phenylbutyrate
glycerol phenylbutyrateGLYCEROL PHENYLBUTYRATELupin Pharmaceuticals, Inc.9bfa912f-c86c-4702-ac99-464c4356d80c2025-06-30Warnings, Adverse reactionsName fallback
brand name: glycerol phenylbutyrate
generic name: GLYCEROL PHENYLBUTYRATE
Glycerol phenylbutyrateGLYCEROL PHENYLBUTYRATETeva Pharmaceuticals, Inc.28bb5ec0-a99f-4774-b8a8-b6c229b89ba52025-03-01Warnings, Adverse reactionsName fallback
brand name: Glycerol phenylbutyrate
generic name: GLYCEROL PHENYLBUTYRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.