FDA.reportPublic FDA data

glycerol phenylbutyrate 1100 MG/ML Oral Solution

RxCUI
1368453
RxNorm name
glycerol phenylbutyrate 1100 MG/ML Oral Solution
Display name
Glycerol phenylbutyrate (Oral Liquid)
Full name
glycerol phenylbutyrate 1100 MG/ML Oral Solution
Term type
SCD
Status
Active
Strength
1,100 mg/ml
Dose form
Sol
Route
Oral Liquid
Updated
2026-10-15 14:47:58

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
032013
Active start
032013
Multiple ingredient
NO
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
glycerol phenylbutyrate1100 MG / 1 MLglycerol phenylbutyrateglycerol phenylbutyrate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Solution316968

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
glycerol phenylbutyrate1368451

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRglycerol phenylbutyrate 1100 MG/ML Oral Solution1NAMES
RxNorm Nameglycerol phenylbutyrate 1100 MG/ML Oral Solution1NAMES
RxNorm Synonymglycerol phenylbutyrate 1.1 GM per 1 ML Oral Solution1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
8 linked values
8CODES
RxCUI13684531CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0480-3777-580480-3777Glycerol phenylbutyrate Glycerol phenylbutyrateTeva Pharmaceuticals, Inc.ANDA218738
31722-605-3131722-605Glycerol Phenylbutyrate Glycerol Phenylbutyrate oralCamber Pharmaceuticals, Inc.ANDA205742
31722-605-3231722-605Glycerol Phenylbutyrate Glycerol Phenylbutyrate oralCamber Pharmaceuticals, Inc.ANDA205742
49884-264-9549884-264Glycerol Phenylbutyrate Glycerol Phenylbutyrate oralPar Health USA, LLCANDA205742
59651-988-2559651-988Glycerol Phenylbutyrate Glycerol PhenylbutyrateAurobindo Pharma LimitedANDA220313
68475-807-0168475-807Glycerol Phenylbutyrate Glycerol PhenylbutyrateNavinta LLCANDA220568
70710-2193-570710-2193Glycerol Phenylbutyrate Glycerol PhenylbutyrateZydus Pharmaceuticals USA Inc.ANDA220568
70748-425-0170748-425glycerol phenylbutyrate glycerol phenylbutyrateLupin Pharmaceuticals, Inc.NDA203284
72205-331-5772205-331Glycerol phenylbutyrate Glycerol phenylbutyrateNovadoz Pharmaceuticals LLCANDA219540
72205-331-5872205-331Glycerol phenylbutyrate Glycerol phenylbutyrateNovadoz Pharmaceuticals LLCANDA219540

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA2187380480-3777Glycerol phenylbutyrate Glycerol phenylbutyrateANDATeva Pharmaceuticals, Inc.
ANDA20574231722-605Glycerol Phenylbutyrate Glycerol Phenylbutyrate oralANDACamber Pharmaceuticals, Inc.
ANDA22031359651-988Glycerol Phenylbutyrate Glycerol PhenylbutyrateANDAAurobindo Pharma Limited
ANDA22056868475-807Glycerol Phenylbutyrate Glycerol PhenylbutyrateANDANavinta LLC
NDA20328470748-425glycerol phenylbutyrate glycerol phenylbutyrateNDALupin Pharmaceuticals, Inc.
ANDA21954072205-331Glycerol phenylbutyrate Glycerol phenylbutyrateANDANovadoz Pharmaceuticals LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 10 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00480377758rxnav_ndcsyes
31722060531rxnav_ndcsyes
31722060532rxnav_ndcsyes
49884026495rxnav_ndcsyes
59651098825rxnav_ndcsyes
68475080701rxnav_ndcsyes
70710219305rxnav_ndcsyes
70748042501rxnav_ndcsyes
72205033157rxnav_ndcsyes
72205033158rxnav_ndcsyes

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 reactionsExact identifier
ndc (package): 31722-605-31
ndc (package): 31722-605-32
ndc (product): 31722-605
ndc11 (package): 31722060531
ndc11 (package): 31722060532
rxcui: 1368453
Glycerol PhenylbutyrateGLYCEROL PHENYLBUTYRATENavinta LLC15c4da9f-f5e0-4628-b55f-3730be3e1c392026-06-23Warnings, Adverse reactionsExact identifier
ndc (package): 68475-807-01
ndc (product): 68475-807
ndc11 (package): 68475080701
rxcui: 1368453
Glycerol phenylbutyrateGLYCEROL PHENYLBUTYRATENovadoz Pharmaceuticals LLCb4dc2c81-3b30-4bb8-af7d-4d093981c3862026-04-16Warnings, Adverse reactionsExact identifier
ndc (package): 72205-331-58
ndc (package): 72205-331-57
ndc (product): 72205-331
ndc11 (package): 72205033157
ndc11 (package): 72205033158
rxcui: 1368453
Glycerol PhenylbutyrateGLYCEROL PHENYLBUTYRATEAurobindo Pharma Limited11981aec-dbf1-4906-acfd-3c10708fe0a62026-04-09Warnings, Adverse reactionsExact identifier
ndc (package): 59651-988-25
ndc (product): 59651-988
ndc11 (package): 59651098825
rxcui: 1368453
Glycerol PhenylbutyrateGLYCEROL PHENYLBUTYRATEZydus Pharmaceuticals USA Inc.c094cb63-3aa0-4564-9c53-7e78f2a563672026-04-01Warnings, Adverse reactionsExact identifier
ndc (package): 70710-2193-5
ndc (product): 70710-2193
ndc11 (package): 70710219305
rxcui: 1368453
RavictiGLYCEROL PHENYLBUTYRATEHorizon Therapeutics USA, Inc.900e7dc0-9afe-4f50-80de-90567bb785192025-10-29Warnings, Adverse reactionsExact identifier
rxcui: 1368453
Glycerol PhenylbutyrateGLYCEROL PHENYLBUTYRATE ORALPar Health USA, LLCe78f2dfd-fb39-4e4b-a639-64591d282ca62025-10-09Warnings, Adverse reactionsExact identifier
ndc (package): 49884-264-95
ndc (product): 49884-264
ndc11 (package): 49884026495
rxcui: 1368453
glycerol phenylbutyrateGLYCEROL PHENYLBUTYRATELupin Pharmaceuticals, Inc.9bfa912f-c86c-4702-ac99-464c4356d80c2025-06-30Warnings, Adverse reactionsExact identifier
ndc (package): 70748-425-01
ndc (product): 70748-425
ndc11 (package): 70748042501
rxcui: 1368453
Glycerol phenylbutyrateGLYCEROL PHENYLBUTYRATETeva Pharmaceuticals, Inc.28bb5ec0-a99f-4774-b8a8-b6c229b89ba52025-03-01Warnings, Adverse reactionsExact identifier
ndc (package): 0480-3777-58
ndc (product): 0480-3777
ndc11 (package): 00480377758
rxcui: 1368453

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 7 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
e78f2dfd-fb39-4e4b-a639-64591d282ca6glycerol phenylbutyrate 1.1 GM in 1 mL Oral Solution [PSN] · glycerol phenylbutyrate 1100 MG/ML Oral Solution [SCD] · glycerol phenylbutyrate 1.1 GM per 1 ML Oral Solution [SY]323These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID . GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 199620251009
900e7dc0-9afe-4f50-80de-90567bb78519glycerol phenylbutyrate 1.1 GM in 1 mL Oral Solution [PSN] · glycerol phenylbutyrate 1100 MG/ML Oral Solution [SCD] · glycerol phenylbutyrate 1.1 GM per 1 ML Oral Solution [SY]313These 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: 199620251029
b4dc2c81-3b30-4bb8-af7d-4d093981c386glycerol phenylbutyrate 1.1 GM in 1 mL Oral Solution [PSN] · glycerol phenylbutyrate 1100 MG/ML Oral Solution [SCD] · glycerol phenylbutyrate 1.1 GM per 1 ML Oral Solution [SY]31These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 199620260416
11981aec-dbf1-4906-acfd-3c10708fe0a6glycerol phenylbutyrate 1.1 GM in 1 mL Oral Solution [PSN] · glycerol phenylbutyrate 1100 MG/ML Oral Solution [SCD] · glycerol phenylbutyrate 1.1 GM per 1 ML Oral Solution [SY]31These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 199620260409
c094cb63-3aa0-4564-9c53-7e78f2a56367glycerol phenylbutyrate 1.1 GM in 1 mL Oral Solution [PSN] · glycerol phenylbutyrate 1100 MG/ML Oral Solution [SCD] · glycerol phenylbutyrate 1.1 GM per 1 ML Oral Solution [SY]31These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 199620260401
9bfa912f-c86c-4702-ac99-464c4356d80cglycerol phenylbutyrate 1.1 GM in 1 mL Oral Solution [PSN] · glycerol phenylbutyrate 1100 MG/ML Oral Solution [SCD] · glycerol phenylbutyrate 1.1 GM per 1 ML Oral Solution [SY]31These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 199620250630
28bb5ec0-a99f-4774-b8a8-b6c229b89ba5glycerol phenylbutyrate 1.1 GM in 1 mL Oral Solution [PSN] · glycerol phenylbutyrate 1100 MG/ML Oral Solution [SCD] · glycerol phenylbutyrate 1.1 GM per 1 ML Oral Solution [SY]31These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID . GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 199620250301

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
d3b52ded-b305-445c-b943-ef0fb2dedd2bThese highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996Camber Pharmaceuticals, Inc. | Annora Pharma Private Limited20260824
15c4da9f-f5e0-4628-b55f-3730be3e1c39These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996Navinta LLC | Apothecon Pharmaceuticals Pvt Ltd20260623
b4dc2c81-3b30-4bb8-af7d-4d093981c386These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996Novadoz Pharmaceuticals LLC | MSN Pharmaceuticals Inc.20260416
11981aec-dbf1-4906-acfd-3c10708fe0a6These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996Aurobindo Pharma Limited20260409
c094cb63-3aa0-4564-9c53-7e78f2a56367These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996Zydus Pharmaceuticals USA Inc. | Navinta LLC | Apothecon Pharmaceuticals Pvt Ltd20260401
e78f2dfd-fb39-4e4b-a639-64591d282ca6These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID . GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996Par Health USA, LLC20251009
9bfa912f-c86c-4702-ac99-464c4356d80cThese highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996Lupin Pharmaceuticals, Inc.20250630
28bb5ec0-a99f-4774-b8a8-b6c229b89ba5These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID . GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996Teva Pharmaceuticals, Inc.20250301

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCA16AXVarious alimentary tract and metabolism productsATC1-4glycerol phenylbutyrate
MEDRTD005990GlycerolCHEMhas_ingredientglycerol phenylbutyrate
MEDRTD010654PhenylbutyratesCHEMhas_ingredientglycerol phenylbutyrate

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH1100 MG/ML (expressed as glycerol phenylbutyrate)
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA205742
CODESANDAANDA218738
CODESANDAANDA219540
CODESANDAANDA220313
CODESANDAANDA220568
CODESNDANDA203284
CODESSNOMEDCT1268426003
CODESVUID4032180
NAMESPrescribable Synonymglycerol phenylbutyrate 1.1 GM in 1 mL Oral Solution
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceUS Edition of SNOMED_CT
SOURCESSourceVeterans Health Administration National Drug File