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United States · US · US:43063-519_4138e87f-3fda-bee4-e063-6294a90afa2b

Hydroxyzine Hydrochloride

SPLATC N05BB01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN05BB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4306351930
    30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-519-30)

Annotations

DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": "ORAL",
  "spl_meta": {
    "4cd84205-6a33-db48-e063-6394a90a9182": {
      "match": "brand_token",
      "title": "HYDROXYZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS, INC.]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "43063-519_4138e87f-3fda-bee4-e063-6294a90afa2b",
  "productndc": "43063-519",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROXYZINE DIHYDROCHLORIDE",
  "proprietary_name": "Hydroxyzine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040788",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydroxyzine Hydrochloride",
  "start_marketing_date": "20120724",
  "active_numerator_strength": "50"
}

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