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United States · US · US:33342-554_4d3cbe46-addd-4a3e-850d-ce502fd5cd26
Trospium Chloride
Orange BookUNIISPLATC G04BD09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeG04BD09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11333425540960 TABLET in 1 BOTTLE (33342-554-09)
- ndc1133342554396 BLISTER PACK in 1 CARTON (33342-554-39) / 15 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
1E6682427E
TROSPIUM CHLORIDE
RxCUI 38891
Orange Book
A206472
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "1E6682427E",
"rxcui": "38891",
"inchikey": "RVCSYOQWLPPAOA-QKYUOBHYSA-M",
"display_name": "TROSPIUM CHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c1c8bd8b-7ff8-5940-e053-2995a90ae656": {
"match": "brand_token",
"title": "TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [SLATE RUN PHARMACEUTICALS, LLC]",
"spl_version": "13",
"published_date": "2026-05-21"
}
},
"productid": "33342-554_4d3cbe46-addd-4a3e-850d-ce502fd5cd26",
"productndc": "33342-554",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "206472",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "001",
"approval_date": "Jun 18, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TROSPIUM CHLORIDE",
"proprietary_name": "Trospium Chloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206472",
"marketing_category": "ANDA",
"nonproprietary_name": "Trospium Chloride",
"start_marketing_date": "20240618",
"active_numerator_strength": "20"
}Related drugs
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Access this data programmatically
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