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United States · US · US:27241-191_cf018a04-660f-4119-898f-1877a5db8e7e
Tolterodine tartrate
Orange BookUNIISPLATC G04BD07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAjanta Pharma USA Inc.
CountryUS (United States)
ATC codeG04BD07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc112724119105500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-191-05)
- ndc11272411913030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-191-30)
- ndc11272411919090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-191-90)
Annotations
UNII (FDA Substance ID)
5T619TQR3R
TOLTERODINE TARTRATE
RxCUI 221174
Orange Book
A213397
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": "27241-191_cf018a04-660f-4119-898f-1877a5db8e7e",
"productndc": "27241-191",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "213397",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "001",
"approval_date": "May 19, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "4MG",
"product_no": "002",
"approval_date": "May 19, 2020"
}
],
"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": "ANDA213397",
"marketing_category": "ANDA",
"nonproprietary_name": "Tolterodine tartrate",
"start_marketing_date": "20200625",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code G04BD07.
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