FESOTERODINE FUMARATE

Orange BookUNIISPLATC G04BD11

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

Identification

ManufacturerCamber Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeG04BD11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
3172203330
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-033-30)
ndc11
3172203390
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-033-90)

Annotations

UNII (FDA Substance ID)

EOS72165S7

FESOTERODINE FUMARATE

RxCUI 797196

Orange Book

A204792

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": "31722-033_2f836bf8-7034-db2e-e063-6394a90a3a3e",
  "productndc": "31722-033",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "204792",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Jan 9, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "002",
        "approval_date": "Jan 9, 2024"
      }
    ],
    "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": "ANDA204792",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FESOTERODINE FUMARATE",
  "start_marketing_date": "20240109",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code G04BD11.

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