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United States · US · US:0069-0244_ca2031f1-5425-4d31-bf14-c865ec4e89b7

Toviaz

Orange BookUNIISPLATC G04BD11

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerPfizer Laboratories Div Pfizer Inc
CountryUS (United States)
ATC codeG04BD11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0069024430
    30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0244-30)

Annotations

UNII (FDA Substance ID)
EOS72165S7
FESOTERODINE FUMARATE
RxCUI 797196
Orange Book
N022030
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": {
    "5be745f0-8ae7-4c3c-9962-37d6263326f1": {
      "match": "brand_token",
      "title": "TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]",
      "spl_version": "33",
      "published_date": "2026-04-09"
    }
  },
  "productid": "0069-0244_ca2031f1-5425-4d31-bf14-c865ec4e89b7",
  "productndc": "0069-0244",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "022030",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Oct 31, 2008"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "002",
        "approval_date": "Oct 31, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FESOTERODINE FUMARATE",
  "proprietary_name": "Toviaz",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022030",
  "marketing_category": "NDA",
  "nonproprietary_name": "fesoterodine fumarate",
  "start_marketing_date": "20081031",
  "active_numerator_strength": "8"
}

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