Quinidine Gluconate

Orange BookUNIISPLATC C01BA01

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeC01BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
5348914101
100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-01)
ndc11
5348914103
250 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-03)
ndc11
5348914105
500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-05)
ndc11
5348914106
60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-06)
ndc11
5348914107
30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-07)
ndc11
5348914110
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-10)
ndc11
5348914190
90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-90)

Annotations

UNII (FDA Substance ID)

R6875N380F

QUINIDINE GLUCONATE

RxCUI 35220

Orange Book

A089338

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "R6875N380F",
    "rxcui": "35220",
    "inchikey": "XHKUDCCTVQUHJQ-LCYSNFERSA-N",
    "display_name": "QUINIDINE GLUCONATE",
    "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": "53489-141_47cec250-341a-4694-a232-93106833a75e",
  "productndc": "53489-141",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "089338",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "324MG",
        "product_no": "001",
        "approval_date": "Feb 11, 1987"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "QUINIDINE GLUCONATE",
  "proprietary_name": "Quinidine Gluconate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA089338",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Quinidine Gluconate",
  "start_marketing_date": "19870210",
  "active_numerator_strength": "324"
}

Related drugs

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