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United States · US · US:50742-238_0a0b38d3-828f-4828-8d8c-92933872aa4f

QUININE SULFATE

Orange BookUNIISPLATC M09AA72

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

Identification

ManufacturerIngenus Pharmaceuticals, LLC
CountryUS (United States)
ATC codeM09AA72
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5074223830
    30 CAPSULE in 1 BOTTLE, PLASTIC (50742-238-30)

Annotations

UNII (FDA Substance ID)
KF7Z0E0Q2B
QUININE SULFATE
RxCUI 9075
Orange Book
A204372
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "KF7Z0E0Q2B",
    "rxcui": "9075",
    "inchikey": "ZHNFLHYOFXQIOW-LPYZJUEESA-N",
    "display_name": "QUININE SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "1f32f05c-a215-40be-b951-e41a7b54a8a0": {
      "match": "brand_token",
      "title": "QUININE SULFATE CAPSULE [LUPIN PHARMACEUTICALS, INC.]",
      "spl_version": "14",
      "published_date": "2025-11-17"
    }
  },
  "productid": "50742-238_0a0b38d3-828f-4828-8d8c-92933872aa4f",
  "productndc": "50742-238",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "204372",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "324MG",
        "product_no": "001",
        "approval_date": "Jul 22, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "QUININE SULFATE",
  "proprietary_name": "QUININE SULFATE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204372",
  "marketing_category": "ANDA",
  "nonproprietary_name": "QUININE SULFATE",
  "start_marketing_date": "20171211",
  "active_numerator_strength": "324"
}

Related drugs

Other records sharing ATC code M09AA72.

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