PROCHLORPERAZINE MALEATE

Orange BookUNIISPLATC N05AB04

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeN05AB04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6318725115
15 TABLET in 1 BOTTLE (63187-251-15)
ndc11
6318725130
30 TABLET in 1 BOTTLE (63187-251-30)
ndc11
6318725160
60 TABLET in 1 BOTTLE (63187-251-60)
ndc11
6318725190
90 TABLET in 1 BOTTLE (63187-251-90)

Annotations

UNII (FDA Substance ID)

I1T8O1JTL6

PROCHLORPERAZINE MALEATE

RxCUI 8706

Orange Book

A040268

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": "63187-251_ba21a8c5-5ab9-4c89-921c-347a068240bc",
  "productndc": "63187-251",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040268",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Feb 27, 1998"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Feb 27, 1998"
      }
    ],
    "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": "ANDA040268",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Prochlorperazine maleate",
  "start_marketing_date": "19980301",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N05AB04.

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