Fesoterodine fumarate

Orange BookUNIISPLATC G04BD11

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

Identification

ManufacturerGolden State Medical Supply, Inc.

CountryUS (United States)

ATC codeG04BD11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5140766230
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-662-30)

Annotations

UNII (FDA Substance ID)

EOS72165S7

FESOTERODINE FUMARATE

RxCUI 797196

Orange Book

A204975

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "EOS72165S7",
    "rxcui": "797196",
    "inchikey": "MWHXMIASLKXGBU-RNCYCKTQSA-N",
    "display_name": "FESOTERODINE FUMARATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "5c5d2a97-9029-744f-c410-a4bbbe9761a8": {
      "match": "brand_token",
      "title": "FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES INC.,]",
      "spl_version": "10",
      "published_date": "2026-05-20"
    }
  },
  "productid": "51407-662_46435eb8-96be-c2df-e063-6294a90acc78",
  "productndc": "51407-662",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "204975",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Aug 13, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "002",
        "approval_date": "Aug 13, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FESOTERODINE FUMARATE",
  "proprietary_name": "Fesoterodine fumarate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204975",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fesoterodine fumarate",
  "start_marketing_date": "20190813",
  "active_numerator_strength": "8"
}

Related drugs

Other records sharing ATC code G04BD11.

Access this data programmatically

Query Fesoterodine fumarate 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