terazosin hydrochloride

Generic: terazosin hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terazosin hydrochloride
Generic Name terazosin hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

terazosin hydrochloride 5 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-595
Product ID 71610-595_2b26376c-c9c8-4d68-aec5-f3aa773fe7f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074823
Listing Expiration 2026-12-31
Marketing Start 2020-06-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610595
Hyphenated Format 71610-595

Supplemental Identifiers

RxCUI
260376 313219
UNII
D32S14F082

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 terazosin hydrochloride (source: ndc)
Generic Name terazosin hydrochloride (source: ndc)
Application Number ANDA074823 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE (71610-595-60)
  • 180 CAPSULE in 1 BOTTLE (71610-595-80)
source: ndc

Packages (2)

71610-595-60 90 CAPSULE in 1 BOTTLE (71610-595-60) 71610-595-80 180 CAPSULE in 1 BOTTLE (71610-595-80)

Ingredients (1)

terazosin hydrochloride (5 mg/1)

Linked Drug Pages (1)

Terazosin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2b26376c-c9c8-4d68-aec5-f3aa773fe7f9", "openfda": {"unii": ["D32S14F082"], "rxcui": ["260376", "313219"], "spl_set_id": ["e5507ea6-bdb3-4363-a68b-0478cbb25f4a"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71610-595-60)", "package_ndc": "71610-595-60", "marketing_start_date": "20210826"}, {"sample": false, "description": "180 CAPSULE in 1 BOTTLE (71610-595-80)", "package_ndc": "71610-595-80", "marketing_start_date": "20210826"}], "brand_name": "Terazosin Hydrochloride", "product_id": "71610-595_2b26376c-c9c8-4d68-aec5-f3aa773fe7f9", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "71610-595", "generic_name": "Terazosin Hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Terazosin Hydrochloride", "active_ingredients": [{"name": "TERAZOSIN HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA074823", "marketing_category": "ANDA", "marketing_start_date": "20200630", "listing_expiration_date": "20261231"}