Procainamide Hydrochloride

Orange BookUNIISPLATC C01BA02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerCaplin Steriles Limited

CountryUS (United States)

ATC codeC01BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6514515610
10 VIAL, MULTI-DOSE in 1 CARTON (65145-156-10) / 2 mL in 1 VIAL, MULTI-DOSE (65145-156-01)

Annotations

UNII (FDA Substance ID)

SI4064O0LX

PROCAINAMIDE HYDROCHLORIDE

RxCUI 155056

Orange Book

A218674

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": "65145-156_b7308804-0dc7-4740-8041-1dd391f950a4",
  "productndc": "65145-156",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "218674",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/ML",
        "product_no": "001",
        "approval_date": "Feb 4, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "500MG/ML",
        "product_no": "002",
        "approval_date": "Feb 4, 2025"
      }
    ],
    "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": "ANDA218674",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Procainamide Hydrochloride",
  "start_marketing_date": "20250217",
  "active_numerator_strength": "500"
}

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