FDA.reportPublic FDA data

NDC 0591-5726-01 - Hydroxyzine Pamoate

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
0591-5726
Requested NDC
0591-5726-01
Package NDCs from labels
0591-5726-01, 0591-5726-05
Manufacturer
Watson Labs
Effective date
2007-01-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydroxyzine Pamoate - Watson LabsWatson Labs2007-01-01HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-5726-01Hydroxyzine Pamoate100 in 1 BOTTLECAPSULE1001
0591-5726-05Hydroxyzine Pamoate500 in 1 BOTTLECAPSULE5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5726HYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]12 package rows20070111_A6EDD742-30B1-4427-BCA8-A81F7EBB2BC6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hydroxyzine PamoateACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]1
HydroxyzineACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]1
D & C Yellow No.10INACTIVE INGREDIENTHYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]1
docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0HYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]1
FD & C Green No. 3INACTIVE INGREDIENTHYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]1
gelatinINACTIVE INGREDIENT2G86QN327LHYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]1
magnesium stearateINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]1
microcrystalline celluloseINACTIVE INGREDIENTHYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUHYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE) CAPSULE [WATSON LABS]1

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 3 of 3 · 51 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine PamoateHYDROXYZINE PAMOATEBryant Ranch Prepackf24c19d4-fd3e-4ed3-aeb7-7bc5e0dd02442023-08-10Warnings, Adverse reactionsExact identifier
rxcui: 995253
hydroxyzine pamoateHYDROXYZINE PAMOATEProficient Rx LPb7f806ed-da18-41f2-aa0b-bce2336f27562022-11-01Warnings, Adverse reactionsExact identifier
rxcui: 995253
Hydroxyzine PamoateHYDROXYZINE PAMOATEProficient Rx LP04657694-e8a8-4e52-a179-cfe7528197602022-11-01Warnings, Adverse reactionsExact identifier
rxcui: 995253
Hydroxyzine PamoateHYDROXYZINE PAMOATEProficient Rx LP23561142-45e0-46f5-b17f-d67760b4db272022-11-01Warnings, Adverse reactionsExact identifier
rxcui: 995253
Hydroxyzine PamoateHYDROXYZINE PAMOATETeva Pharmaceuticals USA, Inc.06068fff-2e79-4721-bcc7-b0938aa20e7a2022-10-01Warnings, Adverse reactionsExact identifier
rxcui: 995253
hydroxyzine pamoateHYDROXYZINE PAMOATESandoz Incc38cfd32-2562-4d6c-8a2e-d9984c16d9eb2022-06-27Warnings, Adverse reactionsExact identifier
rxcui: 995253
Hydroxyzine PamoateHYDROXYZINE PAMOATEProficient Rx LPb098e287-e489-4cdc-9171-7daf50380c1c2022-06-01Warnings, Adverse reactionsExact identifier
rxcui: 995253
Hydroxyzine PamoateHYDROXYZINE PAMOATENCS HealthCare of KY, LLC dba Vangard Labs207d3478-ac7f-485c-b8ca-e9fcebbdcd892022-02-10Warnings, Adverse reactionsExact identifier
rxcui: 995253
Hydroxyzine PamoateHYDROXYZINE PAMOATEAphena Pharma Solutions - Tennessee, LLCd6a1df2e-c111-4ee7-9d56-469db19b7c602021-10-15Warnings, Adverse reactionsExact identifier
rxcui: 995253
hydroxyzine pamoateHYDROXYZINE PAMOATEProficient Rx LPbff75226-d194-4d64-bcbb-d7d79f5d230e2021-05-01Warnings, Adverse reactionsExact identifier
rxcui: 995253
A6EDD742-30B1-4427-BCA8-A81F7EBB2BC6A6EDD742-30B1-4427-BCA8-A81F7EBB2BC62007-01-01Adverse reactionsExact identifier
spl id: A6EDD742-30B1-4427-BCA8-A81F7EBB2BC6
spl set id: A6EDD742-30B1-4427-BCA8-A81F7EBB2BC6

Reported adverse events (FAERS/openFDA)#

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