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 · 8

ndc11
7133523861
10 TABLET, FILM COATED in 1 BOTTLE (71335-2386-1)
ndc11
7133523862
30 TABLET, FILM COATED in 1 BOTTLE (71335-2386-2)
ndc11
7133523863
20 TABLET, FILM COATED in 1 BOTTLE (71335-2386-3)
ndc11
7133523864
60 TABLET, FILM COATED in 1 BOTTLE (71335-2386-4)
ndc11
7133523865
4 TABLET, FILM COATED in 1 BOTTLE (71335-2386-5)
ndc11
7133523866
5 TABLET, FILM COATED in 1 BOTTLE (71335-2386-6)
ndc11
7133523867
100 TABLET, FILM COATED in 1 BOTTLE (71335-2386-7)
ndc11
7133523868
6 TABLET, FILM COATED in 1 BOTTLE (71335-2386-8)

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": "71335-2386_351c034c-50e3-1546-e063-6394a90a7f26",
  "productndc": "71335-2386",
  "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": "10"
}

Related drugs

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