Back to search
🇺🇸

United States · US · US:59762-0800_fdede630-529a-48fe-b796-59c3504c8d32

Tolterodine Tartrate

Orange BookUNIISPLATC G04BD07

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

Identification

ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeG04BD07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5976208002
    60 TABLET, FILM COATED in 1 BOTTLE (59762-0800-2)
  • ndc11
    5976208006
    500 TABLET, FILM COATED in 1 BOTTLE (59762-0800-6)

Annotations

UNII (FDA Substance ID)
5T619TQR3R
TOLTERODINE TARTRATE
RxCUI 221174
Orange Book
N020771
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": {
    "da9423b5-00ab-46fc-8959-3db3c0a0bc6d": {
      "match": "brand_token",
      "title": "TOLTERODINE TARTRATE (TOLTERODINE) CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]",
      "spl_version": "9",
      "published_date": "2026-03-20"
    }
  },
  "productid": "59762-0800_fdede630-529a-48fe-b796-59c3504c8d32",
  "productndc": "59762-0800",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020771",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Mar 25, 1998"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Mar 25, 1998"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TOLTERODINE TARTRATE",
  "proprietary_name": "Tolterodine Tartrate",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020771",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Tolterodine Tartrate",
  "start_marketing_date": "20140121",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code G04BD07.

Access this data programmatically

Query Tolterodine Tartrate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.