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United States · US · US:70954-689_f884dbf6-01ce-4862-bb21-bf41cce2109a

Prochlorperazine Maleate

Orange BookUNIISPLATC N05AB04

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

Identification

ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN05AB04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7095468910
    100 TABLET in 1 BOTTLE (70954-689-10)

Annotations

UNII (FDA Substance ID)
I1T8O1JTL6
PROCHLORPERAZINE MALEATE
RxCUI 8706
Orange Book
A216202
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": "70954-689_f884dbf6-01ce-4862-bb21-bf41cce2109a",
  "productndc": "70954-689",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216202",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Jun 13, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Jun 13, 2022"
      }
    ],
    "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": "ANDA216202",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Prochlorperazine Maleate",
  "start_marketing_date": "20220801",
  "active_numerator_strength": "10"
}

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