PROCHLORPERAZINE MALEATE

Orange BookUNIISPLATC N05AB04

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

Identification

ManufacturerLeading Pharma, LLC

CountryUS (United States)

ATC codeN05AB04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6931526501
100 TABLET, FILM COATED in 1 BOTTLE (69315-265-01)

Annotations

UNII (FDA Substance ID)

I1T8O1JTL6

PROCHLORPERAZINE MALEATE

RxCUI 8706

Orange Book

A218912

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "I1T8O1JTL6",
    "rxcui": "8706",
    "inchikey": "DSKIOWHQLUWFLG-SPIKMXEPSA-N",
    "display_name": "PROCHLORPERAZINE MALEATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d6fc83ad-9cce-4e60-854c-3825313ee60c": {
      "match": "brand_token",
      "title": "PROCHLORPERAZINE MALEATE TABLET [MAJOR PHARMACEUTICALS]",
      "spl_version": "4",
      "published_date": "2026-05-21"
    }
  },
  "productid": "69315-265_e9585ce8-2433-4d85-ab3a-c544d7cb1532",
  "productndc": "69315-265",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "218912",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Sep 30, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Sep 30, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PROCHLORPERAZINE MALEATE",
  "proprietary_name": "PROCHLORPERAZINE MALEATE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA218912",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PROCHLORPERAZINE MALEATE",
  "start_marketing_date": "20250625",
  "active_numerator_strength": "5"
}

Related drugs

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