FDA.reportPublic FDA data

NDC 70710-2193-05 - Glycerol Phenylbutyrate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70710-2193
Requested NDC
70710-2193-05
Package NDCs from labels
70710-2193-5, 70710-2193-05
Manufacturer
Zydus Pharmaceuticals USA Inc. | Navinta LLC | Apothecon Pharmaceuticals Pvt Ltd
Effective date
2026-04-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Glycerol Phenylbutyrate - Zydus Pharmaceuticals USA Inc. | Navinta LLC | Apothecon Pharmaceuticals Pvt LtdZydus Pharmaceuticals USA Inc. | Navinta LLC | Apothecon Pharmaceuticals Pvt Ltd2026-04-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-2193-5Glycerol Phenylbutyrate25 mL in 1 BOTTLELIQUID251
70710-2193-5Glycerol Phenylbutyrate1 in 1 CARTONLIQUID11

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 ยท 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
rxcui: 1368453
unii: ZH6F1VCV7B
Glycerol PhenylbutyrateGLYCEROL PHENYLBUTYRATENavinta LLC15c4da9f-f5e0-4628-b55f-3730be3e1c392026-06-23Warnings, Adverse reactionsExact identifier
application number: ANDA220568
rxcui: 1368453
unii: ZH6F1VCV7B
Glycerol phenylbutyrateGLYCEROL PHENYLBUTYRATENovadoz Pharmaceuticals LLCb4dc2c81-3b30-4bb8-af7d-4d093981c3862026-04-16Warnings, Adverse reactionsExact identifier
rxcui: 1368453
unii: ZH6F1VCV7B
Glycerol PhenylbutyrateGLYCEROL PHENYLBUTYRATEAurobindo Pharma Limited11981aec-dbf1-4906-acfd-3c10708fe0a62026-04-09Warnings, Adverse reactionsExact identifier
rxcui: 1368453
unii: ZH6F1VCV7B
Glycerol PhenylbutyrateGLYCEROL PHENYLBUTYRATEZydus Pharmaceuticals USA Inc.c094cb63-3aa0-4564-9c53-7e78f2a563672026-04-01Warnings, Adverse reactionsExact identifier
application number: ANDA220568
ndc (package): 70710-2193-5
ndc (product): 70710-2193
ndc11 (package): 70710219305
rxcui: 1368453
spl id: 97c20e1a-7e17-4311-9315-f492ff1b0261
spl set id: c094cb63-3aa0-4564-9c53-7e78f2a56367
unii: ZH6F1VCV7B
RavictiGLYCEROL PHENYLBUTYRATEHorizon Therapeutics USA, Inc.900e7dc0-9afe-4f50-80de-90567bb785192025-10-29Warnings, Adverse reactionsExact identifier
rxcui: 1368453
unii: ZH6F1VCV7B
Glycerol PhenylbutyrateGLYCEROL PHENYLBUTYRATE ORALPar Health USA, LLCe78f2dfd-fb39-4e4b-a639-64591d282ca62025-10-09Warnings, Adverse reactionsExact identifier
rxcui: 1368453
unii: ZH6F1VCV7B
glycerol phenylbutyrateGLYCEROL PHENYLBUTYRATELupin Pharmaceuticals, Inc.9bfa912f-c86c-4702-ac99-464c4356d80c2025-06-30Warnings, Adverse reactionsExact identifier
rxcui: 1368453
unii: ZH6F1VCV7B
Glycerol phenylbutyrateGLYCEROL PHENYLBUTYRATETeva Pharmaceuticals, Inc.28bb5ec0-a99f-4774-b8a8-b6c229b89ba52025-03-01Warnings, Adverse reactionsExact identifier
rxcui: 1368453
unii: ZH6F1VCV7B

Reported adverse events (FAERS/openFDA)#

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