Back to search
🇺🇸

United States · US · US:33342-098_fa641ff6-005b-47c5-bade-8709129d7ac9

Tolterodine tartrate

Orange BookUNIISPLATC G04BD07

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

Identification

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

Packs · 3

  • ndc11
    3334209809
    60 TABLET, FILM COATED in 1 BOTTLE (33342-098-09)
  • ndc11
    3334209812
    10 BLISTER PACK in 1 CARTON (33342-098-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    3334209815
    500 TABLET, FILM COATED in 1 BOTTLE (33342-098-15)

Annotations

UNII (FDA Substance ID)
5T619TQR3R
TOLTERODINE TARTRATE
RxCUI 221174
Orange Book
A203409
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": "33342-098_fa641ff6-005b-47c5-bade-8709129d7ac9",
  "productndc": "33342-098",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203409",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Aug 31, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Aug 31, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TOLTERODINE TARTRATE",
  "proprietary_name": "Tolterodine tartrate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203409",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tolterodine tartrate",
  "start_marketing_date": "20201008",
  "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.