FESOTERODINE FUMARATE

Orange BookUNIISPLATC G04BD11

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeG04BD11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6586276630
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-766-30)

Annotations

UNII (FDA Substance ID)

EOS72165S7

FESOTERODINE FUMARATE

RxCUI 797196

Orange Book

A205007

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": "65862-766_33d91059-f2d5-482f-a47f-b1dccb7c5b22",
  "productndc": "65862-766",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "205007",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Feb 17, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "002",
        "approval_date": "Feb 17, 2017"
      }
    ],
    "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": "ANDA205007",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FESOTERODINE FUMARATE",
  "start_marketing_date": "20220617",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code G04BD11.

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