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United States · US · US:51407-002_3bb4ba66-6b1b-ed24-e063-6394a90a37df

hydroxyzine pamoate

Orange BookUNIISPLATC N05BB01

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

Identification

ManufacturerGolden State Medical Supply, Inc.
CountryUS (United States)
ATC codeN05BB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5140700201
    100 CAPSULE in 1 CONTAINER (51407-002-01)
  • ndc11
    5140700205
    500 CAPSULE in 1 CONTAINER (51407-002-05)

Annotations

UNII (FDA Substance ID)
M20215MUFR
HYDROXYZINE PAMOATE
RxCUI 203182
Orange Book
A201507
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "M20215MUFR",
    "rxcui": "203182",
    "inchikey": "ASDOKGIIKXGMNB-UHFFFAOYSA-N",
    "display_name": "HYDROXYZINE PAMOATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "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": "51407-002_3bb4ba66-6b1b-ed24-e063-6394a90a37df",
  "productndc": "51407-002",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "201507",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG HYDROCHLORIDE",
        "product_no": "001",
        "approval_date": "Jun 3, 2013"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG HYDROCHLORIDE",
        "product_no": "002",
        "approval_date": "Jun 3, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROXYZINE PAMOATE",
  "proprietary_name": "hydroxyzine pamoate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA201507",
  "marketing_category": "ANDA",
  "nonproprietary_name": "hydroxyzine pamoate",
  "start_marketing_date": "20130603",
  "active_numerator_strength": "50"
}

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