FDA.reportPublic FDA data

NDC 68071-4954-03 - 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
68071-4954
Requested NDC
68071-4954-03
Package NDCs from labels
68071-4954-3, 68071-4954-9, 68071-4954-03
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-06-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Rx onlyNuCare Pharmaceuticals,Inc.2024-06-18HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-05-16Rx only
2023-01-30Rx only
2021-02-18Rx only
2021-01-29Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4954-3hydroxyzine pamoate30 in 1 BOTTLECAPSULE305
68071-4954-9hydroxyzine pamoate90 in 1 BOTTLECAPSULE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4954HYDROXYZINE PAMOATE CAPSULE [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 2 package rows20240619_8cb94f1d-1e45-531a-e053-2a95a90a1ba0.zip

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 5 · 86 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine pamoateHYDROXYZINE PAMOATEREMEDYREPACK INC.0c9101ee-0746-4833-83cf-d0d09e52c0a92026-08-05Warnings, Adverse reactionsExact identifier
rxcui: 995278
unii: M20215MUFR
hydroxyzine pamoateHYDROXYZINE PAMOATEUnit Dose Solutions, Inc.561d8abe-97e8-5dc7-e063-6294a90a39232026-07-08Warnings, Adverse reactionsExact identifier
rxcui: 995253
unii: M20215MUFR
hydroxyzine pamoateHYDROXYZINE PAMOATEREMEDYREPACK INC.6432d1aa-1e73-469e-835b-43d518963f712026-07-07Warnings, Adverse reactionsExact identifier
rxcui: 995253
unii: M20215MUFR
hydroxyzine pamoateHYDROXYZINE PAMOATEREMEDYREPACK INC.2e59dc14-7e17-4663-bc1f-7ee8e104dbfa2026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 995253
unii: M20215MUFR
hydroxyzine pamoateHYDROXYZINE PAMOATEUnit Dose Solutions, Inc.55012f2c-fa10-2a31-e063-6294a90ae7182026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 995253
unii: M20215MUFR
Hydroxyzine pamoateHYDROXYZINE PAMOATEUnit Dose Solutions, Inc.55033469-f5c6-5180-e063-6394a90af5eb2026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 995278
unii: M20215MUFR
Hydroxyzine pamoateHYDROXYZINE PAMOATEUnit Dose Solutions, Inc.5505ef8f-0322-b705-e063-6394a90a5c5c2026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 995278
unii: M20215MUFR
hydroxyzine pamoateHYDROXYZINE PAMOATECoupler LLC545f0e87-2688-5381-e063-6394a90a72d42026-06-16Warnings, Adverse reactionsExact identifier
rxcui: 995253
unii: M20215MUFR
Hydroxyzine PamoateHYDROXYZINE PAMOATEAmneal Pharmaceuticals of New York LLCbc82aaaf-30c7-4afe-a908-d138ea1268ef2026-06-11Warnings, Adverse reactionsExact identifier
rxcui: 995278
rxcui: 995253
unii: M20215MUFR
hydroxyzine pamoateHYDROXYZINE PAMOATECardinal Health 107, LLC6ffb7c82-f780-4527-a7c3-e7d0f7b3b91e2026-05-18Warnings, Adverse reactionsExact identifier
application number: ANDA201507
rxcui: 995253
unii: M20215MUFR
Hydroxyzine pamoateHYDROXYZINE PAMOATECoupler LLC509e9a9c-23a3-ade4-e063-6294a90a74032026-04-29Warnings, Adverse reactionsExact identifier
rxcui: 995278
unii: M20215MUFR
hydroxyzine pamoateHYDROXYZINE PAMOATECoupler LLC5020c699-6fc5-b166-e063-6294a90a58812026-04-23Warnings, Adverse reactionsExact identifier
application number: ANDA201507
rxcui: 995253
unii: M20215MUFR
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
hydroxyzine pamoateHYDROXYZINE PAMOATEPD-Rx Pharmaceuticals, Inc.98a1c161-5728-4626-a6b0-5414935e4eef2026-03-18Warnings, Adverse reactionsExact identifier
rxcui: 995253
unii: M20215MUFR
Hydroxyzine PamoateHYDROXYZINE PAMOATEDirect_Rx8a7084e0-530c-607b-e053-2a95a90a229c2026-03-05Warnings, Adverse reactionsExact identifier
rxcui: 995253
unii: M20215MUFR
Hydroxyzine PamoateHYDROXYZINE PAMOATEREMEDYREPACK INC.a21df116-501f-4818-ad10-ccfa7b03d7ad2026-02-11Warnings, Adverse reactionsExact identifier
unii: M20215MUFR
hydroxyzine pamoateHYDROXYZINE PAMOATEPreferred Pharmaceuticals Inc.b903f7e1-250d-46d8-a1ec-3f1dabc597f12026-01-23Warnings, Adverse reactionsExact identifier
application number: ANDA201507
rxcui: 995278
unii: M20215MUFR
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Hydroxyzine PamoateHYDROXYZINE PAMOATEAvPAKbff08c15-89b1-00f7-e053-2995a90a2ad82026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 995278
rxcui: 995253
unii: M20215MUFR

Reported adverse events (FAERS/openFDA)#

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