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United States · US · US:70954-592_0d2b0b80-5201-473a-9b43-f5c2127f6f7c
TEZRULY
Orange BookUNIISPLATC G04CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG04CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117095459210150 mL in 1 BOTTLE (70954-592-10)
Annotations
UNII (FDA Substance ID)
D32S14F082
TERAZOSIN HYDROCHLORIDE
RxCUI 235224
Orange Book
N218139
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "D32S14F082",
"rxcui": "235224",
"inchikey": "NZMOFYDMGFQZLS-UHFFFAOYSA-N",
"display_name": "TERAZOSIN HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"69582e0c-6569-490c-8c14-999f3750336f": {
"match": "brand_token",
"title": "TEZRULY (TERAZOSIN) SOLUTION [ANI PHARMACEUTICALS, INC.]",
"spl_version": "3",
"published_date": "2025-04-21"
}
},
"productid": "70954-592_0d2b0b80-5201-473a-9b43-f5c2127f6f7c",
"productndc": "70954-592",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "218139",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 1MG BASE/ML",
"product_no": "001",
"approval_date": "Jul 29, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TERAZOSIN HYDROCHLORIDE",
"proprietary_name": "TEZRULY",
"active_ingred_unit": "mg/mL",
"application_number": "NDA218139",
"marketing_category": "NDA",
"nonproprietary_name": "Terazosin",
"start_marketing_date": "20250418",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code G04CA03.
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