hydroxyzine pamoate

Orange BookUNIISPLATC N05BB01

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeN05BB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
7133512651
30 CAPSULE in 1 BOTTLE (71335-1265-1)
ndc11
7133512652
60 CAPSULE in 1 BOTTLE (71335-1265-2)
ndc11
7133512653
90 CAPSULE in 1 BOTTLE (71335-1265-3)
ndc11
7133512654
8 CAPSULE in 1 BOTTLE (71335-1265-4)
ndc11
7133512655
20 CAPSULE in 1 BOTTLE (71335-1265-5)
ndc11
7133512656
42 CAPSULE in 1 BOTTLE (71335-1265-6)

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": "71335-1265_d9e2251d-75ed-4306-b75c-20e1b145f931",
  "productndc": "71335-1265",
  "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"
}

Related drugs

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