Back to search
🇺🇸

United States · US · US:59762-0047_41ea8bd1-9374-41a1-8a14-f77ec72f0273

Tolterodine Tartrate Extended Release

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
    5976200471
    30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59762-0047-1)
  • ndc11
    5976200472
    90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59762-0047-2)

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": {
    "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": "59762-0047_41ea8bd1-9374-41a1-8a14-f77ec72f0273",
  "productndc": "59762-0047",
  "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": "Tolterodine Tartrate Extended Release",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021228",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "tolterodine tartrate",
  "start_marketing_date": "20160122",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code G04BD07.

Access this data programmatically

Query Tolterodine Tartrate Extended Release 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.