terazosin

Generic: terazosin hydrochloride

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

Drug Facts

Product Profile

Brand Name terazosin
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 71610-503
Product ID 71610-503_b23a32b3-7e6b-4b58-be96-303ac3ef069a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075317
Listing Expiration 2026-12-31
Marketing Start 2020-03-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610503
Hyphenated Format 71610-503

Supplemental Identifiers

RxCUI
313217 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 (source: ndc)
Generic Name terazosin hydrochloride (source: ndc)
Application Number ANDA075317 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE (71610-503-60)
  • 180 CAPSULE in 1 BOTTLE (71610-503-80)
source: ndc

Packages (2)

71610-503-60 90 CAPSULE in 1 BOTTLE (71610-503-60) 71610-503-80 180 CAPSULE in 1 BOTTLE (71610-503-80)

Ingredients (1)

terazosin hydrochloride (5 mg/1)

Linked Drug Pages (1)

Terazosin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b23a32b3-7e6b-4b58-be96-303ac3ef069a", "openfda": {"unii": ["D32S14F082"], "rxcui": ["313217", "313219"], "spl_set_id": ["81d5422c-ff57-4f6d-927c-5de4dd7e1169"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71610-503-60)", "package_ndc": "71610-503-60", "marketing_start_date": "20201208"}, {"sample": false, "description": "180 CAPSULE in 1 BOTTLE (71610-503-80)", "package_ndc": "71610-503-80", "marketing_start_date": "20201208"}], "brand_name": "Terazosin", "product_id": "71610-503_b23a32b3-7e6b-4b58-be96-303ac3ef069a", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "71610-503", "generic_name": "Terazosin Hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Terazosin", "active_ingredients": [{"name": "TERAZOSIN HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA075317", "marketing_category": "ANDA", "marketing_start_date": "20200330", "listing_expiration_date": "20261231"}