fluvoxamine maleate

Orange BookUNIISPLATC N06AB08

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

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeN06AB08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7051816430
30 TABLET, COATED in 1 BLISTER PACK (70518-1643-0)
ndc11
7051816431
50 POUCH in 1 BOX (70518-1643-1) / 1 TABLET, COATED in 1 POUCH (70518-1643-2)

Annotations

UNII (FDA Substance ID)

5LGN83G74V

FLUVOXAMINE MALEATE

RxCUI 203143

Orange Book

N021519

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": "70518-1643_5023bd30-d8fa-9222-e063-6394a90a59e0",
  "productndc": "70518-1643",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "021519",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Dec 20, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Dec 20, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Dec 20, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUVOXAMINE MALEATE",
  "proprietary_name": "fluvoxamine maleate",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021519",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Fluvoxamine maleate",
  "start_marketing_date": "20181007",
  "active_numerator_strength": "50"
}

Related drugs

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