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United States · US · US:71335-2187_c0538532-e7e9-475c-8598-f88bc06b1779

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
    7133521871
    20 CAPSULE in 1 BOTTLE (71335-2187-1)
  • ndc11
    7133521872
    30 CAPSULE in 1 BOTTLE (71335-2187-2)
  • ndc11
    7133521873
    100 CAPSULE in 1 BOTTLE (71335-2187-3)
  • ndc11
    7133521874
    10 CAPSULE in 1 BOTTLE (71335-2187-4)
  • ndc11
    7133521875
    15 CAPSULE in 1 BOTTLE (71335-2187-5)
  • ndc11
    7133521876
    60 CAPSULE in 1 BOTTLE (71335-2187-6)
  • ndc11
    7133521877
    90 CAPSULE in 1 BOTTLE (71335-2187-7)
  • ndc11
    7133521878
    120 CAPSULE in 1 BOTTLE (71335-2187-8)
  • ndc11
    7133521879
    42 CAPSULE in 1 BOTTLE (71335-2187-9)

Annotations

UNII (FDA Substance ID)
M20215MUFR
HYDROXYZINE PAMOATE
RxCUI 203182
Orange Book
A088496
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": "71335-2187_c0538532-e7e9-475c-8598-f88bc06b1779",
  "productndc": "71335-2187",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "088496",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG HYDROCHLORIDE",
        "product_no": "001",
        "approval_date": "Jun 15, 1984"
      }
    ],
    "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": "ANDA088496",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydroxyzine Pamoate",
  "start_marketing_date": "19840701",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code N05BB01.

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