tezruly

Generic: terazosin

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tezruly
Generic Name terazosin
Labeler ani pharmaceuticals, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

terazosin hydrochloride 1 mg/mL

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-592
Product ID 70954-592_0d2b0b80-5201-473a-9b43-f5c2127f6f7c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA218139
Listing Expiration 2026-12-31
Marketing Start 2025-04-18

Pharmacologic Class

Classes
adrenergic alpha-antagonists [moa] alpha-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954592
Hyphenated Format 70954-592

Supplemental Identifiers

RxCUI
2689133 2689139
UPC
0370954592105
UNII
D32S14F082

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tezruly (source: ndc)
Generic Name terazosin (source: ndc)
Application Number NDA218139 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 150 mL in 1 BOTTLE (70954-592-10)
source: ndc

Packages (1)

70954-592-10 150 mL in 1 BOTTLE (70954-592-10)

Ingredients (1)

terazosin hydrochloride (1 mg/mL)

Linked Drug Pages (1)

TEZRULY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0d2b0b80-5201-473a-9b43-f5c2127f6f7c", "openfda": {"upc": ["0370954592105"], "unii": ["D32S14F082"], "rxcui": ["2689133", "2689139"], "spl_set_id": ["69582e0c-6569-490c-8c14-999f3750336f"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "150 mL in 1 BOTTLE (70954-592-10)", "package_ndc": "70954-592-10", "marketing_start_date": "20250418"}], "brand_name": "TEZRULY", "product_id": "70954-592_0d2b0b80-5201-473a-9b43-f5c2127f6f7c", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "70954-592", "generic_name": "Terazosin", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TEZRULY", "active_ingredients": [{"name": "TERAZOSIN HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "NDA218139", "marketing_category": "NDA", "marketing_start_date": "20250418", "listing_expiration_date": "20261231"}