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United States · US · US:65162-811_b1b6d20f-5e99-4205-9f40-fa4a8af3416d

Quinine Sulfate

Orange BookUNIISPLATC M09AA72

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

Identification

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

Packs · 3

  • ndc11
    6516281103
    30 CAPSULE in 1 BOTTLE (65162-811-03)
  • ndc11
    6516281109
    90 CAPSULE in 1 BOTTLE (65162-811-09)
  • ndc11
    6516281150
    500 CAPSULE in 1 BOTTLE (65162-811-50)

Annotations

UNII (FDA Substance ID)
KF7Z0E0Q2B
QUININE SULFATE
RxCUI 9075
Orange Book
A203729
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": "65162-811_b1b6d20f-5e99-4205-9f40-fa4a8af3416d",
  "productndc": "65162-811",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "203729",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "324MG",
        "product_no": "001",
        "approval_date": "Jul 15, 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": "ANDA203729",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Quinine",
  "start_marketing_date": "20160729",
  "active_numerator_strength": "324"
}

Related drugs

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