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United States · US · US:57237-114_c759b18f-8985-4b41-852f-2aa423b32748
Alfuzosin Hydrochloride
Orange BookUNIISPLATC G04CA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeG04CA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc115723711401100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (57237-114-01)
- ndc115723711405500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (57237-114-05)
- ndc11572371149090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (57237-114-90)
Annotations
UNII (FDA Substance ID)
75046A1XTN
ALFUZOSIN HYDROCHLORIDE
RxCUI 46043
Orange Book
A079060
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": {
"37e89394-af6e-4700-bfa8-2effba1a286b": {
"match": "brand_token",
"title": "ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]",
"spl_version": "2",
"published_date": "2026-05-11"
}
},
"productid": "57237-114_c759b18f-8985-4b41-852f-2aa423b32748",
"productndc": "57237-114",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "079060",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Aug 30, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ALFUZOSIN HYDROCHLORIDE",
"proprietary_name": "Alfuzosin Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA079060",
"marketing_category": "ANDA",
"nonproprietary_name": "Alfuzosin Hydrochloride",
"start_marketing_date": "20120830",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code G04CA01.
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