Fesoterodine Fumarate

Orange BookUNIISPLATC G04BD11

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

Identification

ManufacturerAscend Laboratories, LLC

CountryUS (United States)

ATC codeG04BD11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6787706830
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-068-30)
ndc11
6787706890
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-068-90)

Annotations

UNII (FDA Substance ID)

EOS72165S7

FESOTERODINE FUMARATE

RxCUI 797196

Orange Book

A204827

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": "67877-068_2fa76e78-8cb1-49ad-8f23-83ce759112be",
  "productndc": "67877-068",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "204827",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Dec 10, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "002",
        "approval_date": "Dec 10, 2015"
      }
    ],
    "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": "ANDA204827",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fesoterodine Fumarate",
  "start_marketing_date": "20220609",
  "active_numerator_strength": "8"
}

Related drugs

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