Fluvoxamine maleate

Orange BookUNIISPLATC N06AB08

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

Identification

ManufacturerUpsher-Smith Laboratories, LLC

CountryUS (United States)

ATC codeN06AB08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)

5LGN83G74V

FLUVOXAMINE MALEATE

RxCUI 203143

Orange Book

A075888

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": "0832-1670_45afd276-9f2a-23cd-e063-6294a90a0991",
  "productndc": "0832-1670",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "075888",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Nov 29, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Nov 29, 2000"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Nov 29, 2000"
      }
    ],
    "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": "ANDA075888",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluvoxamine maleate",
  "start_marketing_date": "20001129",
  "active_numerator_strength": "25"
}

Related drugs

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