Hydroxyzine Pamoate

Orange BookUNIISPLATC N05BB01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeN05BB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
7120512315
15 CAPSULE in 1 BOTTLE, PLASTIC (71205-123-15)
ndc11
7120512320
20 CAPSULE in 1 BOTTLE, PLASTIC (71205-123-20)
ndc11
7120512330
30 CAPSULE in 1 BOTTLE, PLASTIC (71205-123-30)
ndc11
7120512360
60 CAPSULE in 1 BOTTLE, PLASTIC (71205-123-60)
ndc11
7120512390
90 CAPSULE in 1 BOTTLE, PLASTIC (71205-123-90)

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": "71205-123_a5d8d147-9386-4334-ba38-4052da09ca99",
  "productndc": "71205-123",
  "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": "19960715",
  "active_numerator_strength": "25"
}

Related drugs

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