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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
- ndc11333420980960 TABLET, FILM COATED in 1 BOTTLE (33342-098-09)
- ndc11333420981210 BLISTER PACK in 1 CARTON (33342-098-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
- ndc113334209815500 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.
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