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United States · US · US:14789-901_44fbdf17-cfd1-0076-e063-6394a90abf0d

Procainamide Hydrochloride

Orange BookUNIISPLATC C01BA02

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

Identification

ManufacturerNexus Pharmaceuticals LLC
CountryUS (United States)
ATC codeC01BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1478990110
    10 VIAL, MULTI-DOSE in 1 CARTON (14789-901-10) / 10 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
SI4064O0LX
PROCAINAMIDE HYDROCHLORIDE
RxCUI 155056
Orange Book
A206332
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "SI4064O0LX",
    "rxcui": "155056",
    "inchikey": "ABTXGJFUQRCPNH-UHFFFAOYSA-N",
    "display_name": "PROCAINAMIDE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "17e47845-daad-434c-a784-6d3875b0d704": {
      "match": "brand_token",
      "title": "PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]",
      "spl_version": "25",
      "published_date": "2026-02-11"
    }
  },
  "productid": "14789-901_44fbdf17-cfd1-0076-e063-6394a90abf0d",
  "productndc": "14789-901",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "206332",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/ML",
        "product_no": "001",
        "approval_date": "Oct 13, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "500MG/ML",
        "product_no": "002",
        "approval_date": "Oct 13, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PROCAINAMIDE HYDROCHLORIDE",
  "proprietary_name": "Procainamide Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA206332",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Procainamide Hydrochloride",
  "start_marketing_date": "20071014",
  "active_numerator_strength": "100"
}

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