QUINIDINE SULFATE

Orange BookUNIISPLATC C01BA01

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

Identification

ManufacturerEPIC PHARMA, LLC

CountryUS (United States)

ATC codeC01BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4280651301
100 TABLET in 1 BOTTLE (42806-513-01)
ndc11
4280651330
30 TABLET in 1 BOTTLE (42806-513-30)

Annotations

UNII (FDA Substance ID)

J13S2394HE

QUINIDINE SULFATE

RxCUI 9069

Orange Book

A088072

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "J13S2394HE",
    "rxcui": "9069",
    "inchikey": "ZHNFLHYOFXQIOW-AHSOWCEXSA-N",
    "display_name": "QUINIDINE SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ad2ad985-cca2-25b5-e053-2995a90a402f": {
      "match": "brand_token",
      "title": "QUINIDINE GLUCONATE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY]",
      "spl_version": "2",
      "published_date": "2024-08-29"
    }
  },
  "productid": "42806-513_80df716e-b0d6-4b0f-b0f4-879874d7ed05",
  "productndc": "42806-513",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "088072",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "300MG",
        "product_no": "001",
        "approval_date": "Sep 26, 1983"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "QUINIDINE SULFATE",
  "proprietary_name": "QUINIDINE SULFATE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA088072",
  "marketing_category": "ANDA",
  "nonproprietary_name": "quinidine sulfate tablet",
  "start_marketing_date": "20211215",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code C01BA01.

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