Home NDC 71610-780 Terazosin
Product NDC 71610-780
11-digit product format 716100780
Labeler code 71610
Product ID 71610-780_7bb69c4f-3502-457d-9929-2cb37372202b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Terazosin Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA075317
Marketing category ANDA
Marketing start 2004-12-20
Substance TERAZOSIN HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075317-001 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB RS 2004-12-20 A075317-002 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2004-12-20 A075317-003 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2004-12-20 A075317-004 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2004-12-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 5 · 172 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A075317-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB RS 2004-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075317-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2004-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075317-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2004-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075317-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2004-12-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075317-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB RS 2004-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075317-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2004-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075317-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2004-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075317-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2004-12-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075317-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB RS 2004-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075317-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2004-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075317-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2004-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075317-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2004-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075317-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB RS 2004-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075317-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2004-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075317-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2004-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075317-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2004-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075317-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB RS 2004-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075317-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2004-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075317-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2004-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075317-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2004-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075317-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB RS 2004-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075317-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2004-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075317-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2004-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075317-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2004-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075317-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB RS 2004-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075317-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2004-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075317-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2004-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075317-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2004-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075317-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB RS 2004-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075317-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2004-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075317-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2004-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075317-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2004-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075317-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB RS 2004-12-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075317-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2004-12-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075317-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2004-12-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075317-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2004-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075317-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB RS 2004-12-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075317-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2004-12-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075317-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2004-12-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075317-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2004-12-20 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Terazosin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TERAZOSIN HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D32S14F082 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 260376 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71610-780-60 Terazosin 90 in 1 BOTTLE CAPSULE 90 1 71610-780-80 Terazosin 180 in 1 BOTTLE CAPSULE 180 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-780 TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Current NDC, 2 package rows 20240202_85e450c2-1bc3-49f4-ac2b-5aeedc154bba.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 2 of 2 · 23 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71610-780-60 71610078060 90 CAPSULE in 1 BOTTLE (71610-780-60) 90 capsule 2024-02-01 No No Current 71610-780-80 71610078080 180 CAPSULE in 1 BOTTLE (71610-780-80) 180 capsule 2024-02-01 No No Current