PROCHLORPERAZINE MALEATE

Orange BookUNIISPLATC N05AB04

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN05AB04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
7278951801
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-518-01)
ndc11
7278951815
15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-518-15)
ndc11
7278951890
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-518-90)

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": "72789-518_4603a67f-05af-5931-e063-6394a90afcf3",
  "productndc": "72789-518",
  "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": "20250728",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N05AB04.

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