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United States · US · US:55154-4183_5ad400a8-04d3-42e7-84b7-b5da30dcb859

Prochlorperazine Edisylate

Orange BookUNIISPLATC N05AB04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerCardinal Health 107, LLC
CountryUS (United States)
ATC codeN05AB04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5515441835
    5 VIAL in 1 BAG (55154-4183-5) / 2 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
PG20W5VQZS
PROCHLORPERAZINE EDISYLATE
RxCUI 8705
Orange Book
A204147
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "PG20W5VQZS",
    "rxcui": "8705",
    "inchikey": "SWOUGRBFXFILIB-UHFFFAOYSA-N",
    "display_name": "PROCHLORPERAZINE EDISYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "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": "55154-4183_5ad400a8-04d3-42e7-84b7-b5da30dcb859",
  "productndc": "55154-4183",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "204147",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 5MG BASE/ML",
        "product_no": "001",
        "approval_date": "Oct 15, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PROCHLORPERAZINE EDISYLATE",
  "proprietary_name": "Prochlorperazine Edisylate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA204147",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Prochlorperazine Edisylate",
  "start_marketing_date": "20120326",
  "active_numerator_strength": "5"
}

Related drugs

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