FDA.reportPublic FDA data

NDC 80425-0173-01 - Hydroxyzine HCL

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
80425-0173
Requested NDC
80425-0173-01
Package NDCs from labels
80425-0173-1, 80425-0173-2, 80425-0173-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-04-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydroxyzine HCL - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-04-25HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0173-1Hydroxyzine HCL30 in 1 BOTTLETABLET, FILM COATED304
80425-0173-2Hydroxyzine HCL60 in 1 BOTTLETABLET, FILM COATED604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0173HYDROXYZINE HCL TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]4Current NDC, Legacy NDC, 2 package rows20240426_cd4ea0ea-0d92-b70c-e053-2995a90a62ce.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0173-1EA - Each80425-0173189b2f12-a828-44bd-97c6-03bcf942b1f612023-06-06
80425-0173-2EA - Each80425-0173918f2b72-6f78-472c-8c98-5731318aa3b412024-06-10

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 8 · 151 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.58d99cf6-2319-410b-b8be-de9c304541b62026-09-08Warnings, Adverse reactionsExact identifier
rxcui: 995218
unii: 76755771U3
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDECoupler LLC5a586fc0-e4e0-5621-e063-6294a90a222b2026-08-31Warnings, Adverse reactionsExact identifier
rxcui: 995281
unii: 76755771U3
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.8f41912e-12ce-4174-a0fb-cfb4888d8d582026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 995258
unii: 76755771U3
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDECoupler LLC583b0ad8-012d-06e5-e063-6294a90a9b122026-08-04Warnings, Adverse reactionsExact identifier
rxcui: 995218
unii: 76755771U3
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDESt Mary's Medical Park Pharmacy9ef6a4b7-362d-61b4-e053-2995a90a0ebb2026-07-28Warnings, Adverse reactionsExact identifier
rxcui: 995218
unii: 76755771U3
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions5dea636d-dee6-47d4-b83c-b9f0c0b1b6ca2026-07-24Warnings, Adverse reactionsExact identifier
rxcui: 995218
unii: 76755771U3
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy30b6f7b3-b620-961a-e063-6394a90a487b2026-07-23Warnings, Adverse reactionsExact identifier
rxcui: 995258
unii: 76755771U3
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.ca67c061-c743-4ebb-a9d5-ece4880606632026-07-22Warnings, Adverse reactionsExact identifier
rxcui: 995258
unii: 76755771U3
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEAPOZEAL PHARMACEUTICALS INC87d4bbff-0498-4c26-86cb-7ce173afa0b62026-07-21Warnings, Adverse reactionsExact identifier
unii: 76755771U3
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutionsbe6a2f09-c0f3-44e2-aac3-37e3702b93f02026-07-21Warnings, Adverse reactionsExact identifier
rxcui: 995281
unii: 76755771U3
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDECardinal Health 107, LLCb4d274ce-d616-4835-80ce-76270524ed362026-07-20Warnings, Adverse reactionsExact identifier
rxcui: 995258
unii: 76755771U3
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEMajor Pharmaceuticals7f76580c-96a0-4b56-8986-ff5488bb98692026-07-15Warnings, Adverse reactionsExact identifier
rxcui: 995218
rxcui: 995281
rxcui: 995258
unii: 76755771U3
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.bb4a7d22-2f42-4e9f-bf98-cee43ed14d502026-07-15Warnings, Adverse reactionsExact identifier
rxcui: 995281
unii: 76755771U3
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEPreferred Pharmaceuticals Incc8b441bf-a03e-47b3-8f06-c347f5ca4b702026-07-15Warnings, Adverse reactionsExact identifier
rxcui: 995218
unii: 76755771U3
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.b6189074-e199-4f58-a78d-c04f131c13d92026-07-10Warnings, Adverse reactionsExact identifier
rxcui: 995258
unii: 76755771U3
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.aa9523e0-c95d-4213-b213-96170d8555362026-07-10Warnings, Adverse reactionsExact identifier
rxcui: 995258
unii: 76755771U3
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC5648abce-f20e-717c-e063-6294a90a88ac2026-07-10Warnings, Adverse reactionsExact identifier
rxcui: 995258
unii: 76755771U3
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack66be7bde-d2bd-4c65-bde9-0fb9f5be093f2026-07-02Warnings, Adverse reactionsExact identifier
rxcui: 995258
unii: 76755771U3
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEProficient Rx LP83e8d60d-36fd-4223-b50c-e6615045352a2026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 995258
unii: 76755771U3
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEUnit Dose Solutions, Inc.5506e802-0efc-a845-e063-6394a90aad0e2026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 995281
unii: 76755771U3

Reported adverse events (FAERS/openFDA)#

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