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United States · US · US:58151-104_0ca22b08-46d1-4b6f-b9e7-d6a5dd534a1c

Detrol LA

Orange BookUNIISPLATC G04BD07

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

Identification

ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeG04BD07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5815110477
    90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58151-104-77)
  • ndc11
    5815110493
    30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58151-104-93)

Annotations

UNII (FDA Substance ID)
5T619TQR3R
TOLTERODINE TARTRATE
RxCUI 221174
Orange Book
N021228
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "5T619TQR3R",
    "rxcui": "221174",
    "inchikey": "TWHNMSJGYKMTRB-KXYUELECSA-N",
    "display_name": "TOLTERODINE TARTRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d7274947-4f88-47ee-a39f-bd5ac46fcf8d": {
      "match": "brand_token",
      "title": "DETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [VIATRIS SPECIALTY LLC]",
      "spl_version": "5",
      "published_date": "2026-02-26"
    }
  },
  "productid": "58151-104_0ca22b08-46d1-4b6f-b9e7-d6a5dd534a1c",
  "productndc": "58151-104",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "021228",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Dec 22, 2000"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "002",
        "approval_date": "Dec 22, 2000"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TOLTERODINE TARTRATE",
  "proprietary_name": "Detrol LA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021228",
  "marketing_category": "NDA",
  "nonproprietary_name": "tolterodine tartrate",
  "start_marketing_date": "20240320",
  "active_numerator_strength": "4"
}

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