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United States · US · US:59212-200_ffbc758d-7556-4269-8947-baa7ddb88541
Uroxatral
Orange BookUNIISPLATC G04CA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanz Pharma (US) Corp.
CountryUS (United States)
ATC codeG04CA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc115921220010100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-200-10)
- ndc11592122003030 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-200-30)
Annotations
UNII (FDA Substance ID)
75046A1XTN
ALFUZOSIN HYDROCHLORIDE
RxCUI 46043
Orange Book
N021287
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "75046A1XTN",
"rxcui": "46043",
"inchikey": "YTNKWDJILNVLGX-UHFFFAOYSA-N",
"display_name": "ALFUZOSIN HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"9fc7f119-f36b-44cf-945d-940160f3afe3": {
"match": "brand_token",
"title": "UROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [ADVANZ PHARMA (US) CORP.]",
"spl_version": "9",
"published_date": "2025-01-03"
}
},
"productid": "59212-200_ffbc758d-7556-4269-8947-baa7ddb88541",
"productndc": "59212-200",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "021287",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Jun 12, 2003"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ALFUZOSIN HYDROCHLORIDE",
"proprietary_name": "Uroxatral",
"active_ingred_unit": "mg/1",
"application_number": "NDA021287",
"marketing_category": "NDA",
"nonproprietary_name": "Alfuzosin HCl",
"start_marketing_date": "20130603",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code G04CA01.
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