FDA.reportPublic FDA data

Application 040842

Type
ANDA
Sponsor
NORTHSTAR HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDETABLET;ORAL25MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 4 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEA-S Medication Solutionsa9a133e6-efce-4bdb-9335-49c74e57fafe2025-11-01Warnings, Adverse reactionsName fallback
brand name: HYDROXYZINE HYDROCHLORIDE
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEHenry Schein, Inc.7279ad5a-0a49-432d-8fa2-17e4c6ecbadc2025-10-31Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.7165a30c-09e4-4ca1-8548-bf71998ba12f2025-10-20Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.4789b7ae-314c-43c0-ad33-92ff50085f272025-10-17Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1a3e389f-391d-4f37-9e34-ce3c6f5fe8c12025-10-17Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.24cb9c83-a7e4-4bae-997c-c3a87426f78c2025-10-15Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.263d3f22-a105-4abb-8152-be2081eefcde2025-10-15Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.cc6a12ed-411b-4b0c-8108-58ef7db8da552025-10-15Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepackeef36dab-c318-44d2-8583-7bae3bfceee72025-10-13Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEDirect Rxd956063a-ef48-faca-e053-2995a90a02912025-10-06Name fallback
brand name: HYDROXYZINE HYDROCHLORIDE
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAmerican Health Packagingfc148d96-b868-4e45-b7d2-977faf4310492025-09-15Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack93d117dd-e2bf-4daa-abe3-d4fefed3313c2025-09-11Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack3f90259a-a684-498f-8963-d02eaba2e9db2025-09-08Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack9c2c05e0-b123-4ddf-8b07-6bb3ca0678b52025-09-08Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.2b05bd0e-af57-4e74-92f8-a4311330142f2025-08-18Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.214b3f14-2f6c-4f36-b7a6-e0b1f820e3a72025-08-18Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDERising Pharma Holdings, Inc.6a1a48ac-8ad5-4363-b298-d9825ae2a4482025-08-14Warnings, Adverse reactionsName fallback
brand name: HYDROXYZINE HYDROCHLORIDE
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.80309ec1-e5d5-4454-b8ce-67d7e6805e442025-07-31Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDE ORALBionpharma Inc.39f93633-000e-6c3f-e063-6394a90a5a0b2025-07-15Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ca015a35-1f94-4f92-9143-3f149982d3162025-07-15Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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