Fluvoxamine Maleate

Orange BookUNIISPLATC N06AB08

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

Identification

ManufacturerBionpharma Inc.

CountryUS (United States)

ATC codeN06AB08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6945218313
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69452-183-13)
ndc11
6945218332
1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69452-183-32)

Annotations

UNII (FDA Substance ID)

5LGN83G74V

FLUVOXAMINE MALEATE

RxCUI 203143

Orange Book

A212182

ABAB

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": "69452-183_19874c71-b387-6008-e063-6294a90ab365",
  "productndc": "69452-183",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "212182",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "May 11, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Sep 16, 2020"
      }
    ],
    "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": "ANDA212182",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluvoxamine Maleate",
  "start_marketing_date": "20200701",
  "active_numerator_strength": "150"
}

Related drugs

Other records sharing ATC code N06AB08.

Access this data programmatically

Query Fluvoxamine Maleate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs