Fluvoxamine Maleate

Orange BookUNIISPLATC N06AB08

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.

CountryUS (United States)

ATC codeN06AB08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6878881753
30 TABLET in 1 BOTTLE (68788-8175-3)
ndc11
6878881756
60 TABLET in 1 BOTTLE (68788-8175-6)
ndc11
6878881759
90 TABLET in 1 BOTTLE (68788-8175-9)

Annotations

UNII (FDA Substance ID)

5LGN83G74V

FLUVOXAMINE MALEATE

RxCUI 203143

Orange Book

A075902

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": "68788-8175_e8faf176-d195-4e5f-a7dc-a17a05985ec6",
  "productndc": "68788-8175",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075902",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "May 7, 2001"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "May 7, 2001"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "May 7, 2001"
      }
    ],
    "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": "ANDA075902",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluvoxamine Maleate",
  "start_marketing_date": "20220427",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code N06AB08.

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