PROCHLORPERAZINE MALEATE

Orange BookUNIISPLATC N05AB04

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeN05AB04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
7133526211
20 TABLET, FILM COATED in 1 BOTTLE (71335-2621-1)
ndc11
7133526212
10 TABLET, FILM COATED in 1 BOTTLE (71335-2621-2)
ndc11
7133526213
30 TABLET, FILM COATED in 1 BOTTLE (71335-2621-3)
ndc11
7133526214
60 TABLET, FILM COATED in 1 BOTTLE (71335-2621-4)
ndc11
7133526215
90 TABLET, FILM COATED in 1 BOTTLE (71335-2621-5)
ndc11
7133526216
120 TABLET, FILM COATED in 1 BOTTLE (71335-2621-6)
ndc11
7133526217
6 TABLET, FILM COATED in 1 BOTTLE (71335-2621-7)

Annotations

UNII (FDA Substance ID)

I1T8O1JTL6

PROCHLORPERAZINE MALEATE

RxCUI 8706

Orange Book

A217478

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": "71335-2621_9002b9dd-0012-4f2e-8770-3e8a8ef463f9",
  "productndc": "71335-2621",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "217478",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Apr 4, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Apr 4, 2023"
      }
    ],
    "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": "ANDA217478",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Prochlorperazine Maleate",
  "start_marketing_date": "20230913",
  "active_numerator_strength": "5"
}

Related drugs

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