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United States · US · US:0115-1804_bfba144b-f9a0-46c4-b55c-fe452bcd9f57

Hydroxyzine Pamoate

Orange BookUNIISPLATC N05BB01

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

Identification

ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeN05BB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0115180401
    100 CAPSULE in 1 BOTTLE, PLASTIC (0115-1804-01)
  • ndc11
    0115180402
    500 CAPSULE in 1 BOTTLE, PLASTIC (0115-1804-02)

Annotations

UNII (FDA Substance ID)
M20215MUFR
HYDROXYZINE PAMOATE
RxCUI 203182
Orange Book
A040156
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": "0115-1804_bfba144b-f9a0-46c4-b55c-fe452bcd9f57",
  "productndc": "0115-1804",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "040156",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG HYDROCHLORIDE",
        "product_no": "001",
        "approval_date": "Jul 15, 1996"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG HYDROCHLORIDE",
        "product_no": "002",
        "approval_date": "Jul 15, 1996"
      }
    ],
    "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": "ANDA040156",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydroxyzine Pamoate",
  "start_marketing_date": "19960615",
  "active_numerator_strength": "50"
}

Related drugs

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