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United States · US · US:55150-360_5287e3a1-7470-4fd2-a9ea-acddf25ee83e

Prochlorperazine Edisylate

Orange BookUNIISPLATC N05AB04

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

Identification

ManufacturerEugia US LLC
CountryUS (United States)
ATC codeN05AB04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5515036001
    1 VIAL, MULTI-DOSE in 1 CARTON (55150-360-01) / 2 mL in 1 VIAL, MULTI-DOSE
  • ndc11
    5515036025
    25 VIAL, MULTI-DOSE in 1 CARTON (55150-360-25) / 2 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
PG20W5VQZS
PROCHLORPERAZINE EDISYLATE
RxCUI 8705
Orange Book
A213873
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": "55150-360_5287e3a1-7470-4fd2-a9ea-acddf25ee83e",
  "productndc": "55150-360",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "213873",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 5MG BASE/ML",
        "product_no": "001",
        "approval_date": "Jul 14, 2022"
      }
    ],
    "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": "ANDA213873",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Prochlorperazine Edisylate",
  "start_marketing_date": "20220714",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code N05AB04.

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