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United States · US · US:70436-161_44e07d95-cc64-cae9-e063-6294a90abc45
Tolterodine Tartrate
Orange BookUNIISPLATC G04BD07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSlate Run Pharmaceuticals, LLC
CountryUS (United States)
ATC codeG04BD07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc117043616102500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-161-02)
- ndc11704361610430 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-161-04)
- ndc11704361610690 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-161-06)
Annotations
UNII (FDA Substance ID)
5T619TQR3R
TOLTERODINE TARTRATE
RxCUI 221174
Orange Book
A213858
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": "70436-161_44e07d95-cc64-cae9-e063-6294a90abc45",
"productndc": "70436-161",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "213858",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "001",
"approval_date": "Feb 2, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "4MG",
"product_no": "002",
"approval_date": "Feb 2, 2021"
}
],
"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": "ANDA213858",
"marketing_category": "ANDA",
"nonproprietary_name": "Tolterodine Tartrate",
"start_marketing_date": "20210412",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code G04BD07.
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