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United States · US · US:33342-384_4a96f732-bbce-426f-9780-89115cac638b
Silodosin
Orange BookUNIISPLATC G04CA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeG04CA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11333423840730 CAPSULE in 1 BOTTLE (33342-384-07)
- ndc11333423841090 CAPSULE in 1 BOTTLE (33342-384-10)
- ndc113334238412100 BLISTER PACK in 1 CARTON (33342-384-12) / 10 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
CUZ39LUY82
SILODOSIN
RxCUI 720825
Orange Book
A211166
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "CUZ39LUY82",
"rxcui": "720825",
"inchikey": "PNCPYILNMDWPEY-QGZVFWFLSA-N",
"display_name": "SILODOSIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"43f83422-680f-411e-bbc3-2b092e64a017": {
"match": "brand_token",
"title": "SILODOSIN CAPSULE [CREEKWOOD PHARMACEUTICALS LLC]",
"spl_version": "4",
"published_date": "2026-05-11"
}
},
"productid": "33342-384_4a96f732-bbce-426f-9780-89115cac638b",
"productndc": "33342-384",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "211166",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "4MG",
"product_no": "001",
"approval_date": "Dec 3, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "8MG",
"product_no": "002",
"approval_date": "Dec 3, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SILODOSIN",
"proprietary_name": "Silodosin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211166",
"marketing_category": "ANDA",
"nonproprietary_name": "Silodosin",
"start_marketing_date": "20181203",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code G04CA04.
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