fesoterodine fumarate

Orange BookUNIISPLATC G04BD11

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeG04BD11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6838247906
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-479-06)
ndc11
6838247916
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-479-16)
ndc11
6838247977
10 BLISTER PACK in 1 CARTON (68382-479-77) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68382-479-30)

Annotations

UNII (FDA Substance ID)

EOS72165S7

FESOTERODINE FUMARATE

RxCUI 797196

Orange Book

A204946

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": "68382-479_3e1e7df1-1de5-4500-bcd3-1c9ae36a60d5",
  "productndc": "68382-479",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "204946",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Oct 3, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "002",
        "approval_date": "Oct 3, 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": "ANDA204946",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fesoterodine fumarate",
  "start_marketing_date": "20171207",
  "active_numerator_strength": "4"
}

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