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United States · US · US:51662-1334_11c18bb0-a2ec-54f0-e063-6294a90a57c3

PROCAINAMIDE HCI

Orange BookUNIISPLATC C01BA02

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

Identification

ManufacturerHF Acquisition Co LLC, DBA HealthFirst
CountryUS (United States)
ATC codeC01BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5166213341
    1 VIAL, MULTI-DOSE in 1 CARTON (51662-1334-1) / 10 mL in 1 VIAL, MULTI-DOSE
  • ndc11
    5166213343
    25 POUCH in 1 BOX (51662-1334-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1334-2) / 10 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
SI4064O0LX
PROCAINAMIDE HYDROCHLORIDE
RxCUI 155056
Orange Book
A089069
AP
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": "51662-1334_11c18bb0-a2ec-54f0-e063-6294a90a57c3",
  "productndc": "51662-1334",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "089069",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/ML",
        "product_no": "001",
        "approval_date": "Feb 12, 1986"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PROCAINAMIDE HYDROCHLORIDE",
  "proprietary_name": "PROCAINAMIDE HCI",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA089069",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PROCAINAMIDE HCI",
  "start_marketing_date": "20190210",
  "active_numerator_strength": "100"
}

Related drugs

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