FDA.reportPublic FDA data

Application 040841

Type
ANDA
Sponsor
NORTHSTAR HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDETABLET;ORAL10MGNoNo

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 3 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc4aa896b1-4fd5-513e-e063-6294a90ab9502026-02-12Warnings, Adverse reactionsName fallback
brand name: HYDROXYZINE HYDROCHLORIDE
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions1350964e-663e-4a50-8c4c-cda371a694a02026-02-04Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS19fe26a9-eb1a-4c5b-a5e4-65223ee56ad12026-02-02Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.6ad55cd1-a284-4c3d-aa90-653704afdb752026-01-30Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.4c2c4d8e-c3d1-48c7-8f99-ffa1596674652026-01-19Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDENorthwind Health Company, LLCf2b3d10f-2599-5b71-e053-2a95a90a54bb2026-01-01Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDENorthwind Health Company, LLCdb0dce55-5984-7580-e053-2a95a90a36952026-01-01Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDENorthwind Health Company, LLCf30879f6-d6e3-1f87-e053-2995a90abca92026-01-01Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDENorthwind Health Company, LLCc134195e-a048-530a-e053-2a95a90ad9f82025-12-26Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDENorthwind Health Company, LLCc13455a3-3078-4fe1-e053-2a95a90adf8e2025-12-26Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDENorthstar RxLLC8e5fce17-936e-46ea-a969-518c952c20912025-12-23Warnings, Adverse reactionsName fallback
brand name: HydrOXYzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEChartwell RX, LLC6533bb4f-efbc-4fca-b625-daa1b39787402025-12-10Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack3526a66b-2182-4b5a-a7d1-563d75f5335f2025-12-03Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack9504897e-febc-4293-a2dc-9f79f55ea8212025-12-03Warnings, Adverse reactionsName fallback
brand name: Hydroxyzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEA-S Medication Solutionsafa74394-c079-4ad3-b555-270fe0de3d622025-12-02Warnings, Adverse reactionsName fallback
brand name: HYDROXYZINE HYDROCHLORIDE
generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions69a58bc6-c8a4-48ad-ac77-90fac42e03982025-12-02Warnings, Adverse reactionsName fallback
brand name: HYDROXYZINE HYDROCHLORIDE
generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEA-S Medication Solutionsa8525244-2acb-4e3e-9769-bbc90549a1882025-12-02Warnings, Adverse reactionsName fallback
brand name: HYDROXYZINE HYDROCHLORIDE
generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions87b79b7c-0398-47dc-858d-62e44a1b02f42025-12-02Warnings, Adverse reactionsName fallback
brand name: HYDROXYZINE HYDROCHLORIDE
generic name: HYDROXYZINE HYDROCHLORIDE
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.acc99b8f-87f0-eb3a-e053-2995a90aaaed2025-11-20Warnings, Adverse reactionsName fallback
brand name: HydrOXYzine Hydrochloride
generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEChartwell Governmental & Specialty RX, LLC.0de7a377-7a8f-4119-b172-1eadb4b7e1be2025-11-11Warnings, 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.