Fluvoxamine maleate

Orange BookUNIISPLATC N06AB08

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeN06AB08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009077280
90 TABLET in 1 BOTTLE (50090-7728-0)

Annotations

UNII (FDA Substance ID)

5LGN83G74V

FLUVOXAMINE MALEATE

RxCUI 203143

Orange Book

A217917

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "5LGN83G74V",
    "rxcui": "203143",
    "inchikey": "LFMYNZPAVPMEGP-PIDGMYBPSA-N",
    "display_name": "FLUVOXAMINE MALEATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "5198b1c8-8dd6-4b8f-bd85-294ac468af53": {
      "match": "brand_token",
      "title": "FLUVOXAMINE MALEATE TABLET, COATED [REMEDYREPACK INC.]",
      "spl_version": "16",
      "published_date": "2026-04-27"
    }
  },
  "productid": "50090-7728_eaa06ce9-31b7-4a55-b075-fe88cb86de8a",
  "productndc": "50090-7728",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "217917",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Jan 22, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Jan 22, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Jan 22, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUVOXAMINE MALEATE",
  "proprietary_name": "Fluvoxamine maleate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA217917",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluvoxamine maleate",
  "start_marketing_date": "20250207",
  "active_numerator_strength": "100"
}

Related drugs

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