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United States · US · US:43353-945_15c875e9-bc9e-4d06-83f5-0cc5c6742302
Alfuzosin hydrochloride
Orange BookUNIISPLATC G04CA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeG04CA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1143353945166000 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-945-16)
- ndc11433539453030 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-945-30)
- ndc11433539456090 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-945-60)
Annotations
UNII (FDA Substance ID)
75046A1XTN
ALFUZOSIN HYDROCHLORIDE
RxCUI 46043
Orange Book
A090284
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": "43353-945_15c875e9-bc9e-4d06-83f5-0cc5c6742302",
"productndc": "43353-945",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "090284",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Jan 17, 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": "ANDA090284",
"marketing_category": "ANDA",
"nonproprietary_name": "Alfuzosin hydrochloride",
"start_marketing_date": "20121002",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code G04CA01.
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