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United States · US · US:71335-1714_b80b0312-5c65-4bfd-a619-5a7c9ce6e3c7

hydroxyzine pamoate

Orange BookUNIISPLATC N05BB01

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN05BB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 9

  • ndc11
    7133517141
    20 CAPSULE in 1 BOTTLE (71335-1714-1)
  • ndc11
    7133517142
    30 CAPSULE in 1 BOTTLE (71335-1714-2)
  • ndc11
    7133517143
    100 CAPSULE in 1 BOTTLE (71335-1714-3)
  • ndc11
    7133517144
    10 CAPSULE in 1 BOTTLE (71335-1714-4)
  • ndc11
    7133517145
    15 CAPSULE in 1 BOTTLE (71335-1714-5)
  • ndc11
    7133517146
    60 CAPSULE in 1 BOTTLE (71335-1714-6)
  • ndc11
    7133517147
    90 CAPSULE in 1 BOTTLE (71335-1714-7)
  • ndc11
    7133517148
    120 CAPSULE in 1 BOTTLE (71335-1714-8)
  • ndc11
    7133517149
    42 CAPSULE in 1 BOTTLE (71335-1714-9)

Annotations

UNII (FDA Substance ID)
M20215MUFR
HYDROXYZINE PAMOATE
RxCUI 203182
Orange Book
A087479
AB
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": "71335-1714_b80b0312-5c65-4bfd-a619-5a7c9ce6e3c7",
  "productndc": "71335-1714",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "087479",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG HYDROCHLORIDE",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "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": "ANDA087479",
  "marketing_category": "ANDA",
  "nonproprietary_name": "hydroxyzine pamoate",
  "start_marketing_date": "19811214",
  "active_numerator_strength": "25"
}

Related drugs

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