Home NDC 71610-854 Terazosin Hydrochloride
Product NDC 71610-854
11-digit product format 716100854
Labeler code 71610
Product ID 71610-854_214d9180-c434-330d-e063-6394a90a795c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Terazosin Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA074823
Marketing category ANDA
Marketing start 2020-06-30
Substance TERAZOSIN HYDROCHLORIDE
Active strength 1 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 1 .
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 A074823-001 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 1998-03-30 A074823-002 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 1998-03-30 A074823-003 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 1998-03-30 A074823-004 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 1998-03-30
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 · 164 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 2026-02-19 14:30 UTC 2026-02 A074823-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 1998-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074823-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 1998-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074823-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 1998-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074823-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 1998-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074823-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 1998-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074823-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 1998-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074823-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 1998-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074823-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 1998-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074823-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 1998-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074823-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 1998-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074823-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 1998-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074823-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 1998-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074823-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 1998-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074823-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 1998-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074823-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 1998-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074823-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 1998-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074823-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 1998-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074823-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 1998-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074823-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 1998-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074823-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 1998-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074823-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 1998-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074823-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 1998-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074823-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 1998-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074823-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 1998-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074823-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 1998-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074823-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 1998-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074823-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 1998-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074823-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 1998-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074823-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 1998-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074823-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 1998-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074823-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 1998-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074823-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 1998-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074823-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 1998-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074823-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 1998-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074823-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 1998-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074823-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 1998-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074823-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 1998-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074823-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 1998-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074823-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 1998-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074823-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 1998-03-30 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Terazosin Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TERAZOSIN HYDROCHLORIDE 1 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 313215 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 71610-854-30 Terazosin Hydrochloride 30 in 1 BOTTLE CAPSULE 30 1 71610-854-53 Terazosin Hydrochloride 60 in 1 BOTTLE CAPSULE 60 1 71610-854-60 Terazosin Hydrochloride 90 in 1 BOTTLE CAPSULE 90 1 71610-854-80 Terazosin Hydrochloride 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 71610-854 TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ] 1 Current NDC, 4 package rows 20240906_214d9b06-8d23-3ee8-e063-6394a90a1521.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 1 of 1 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Terazosin Hydrochloride TERAZOSIN HYDROCHLORIDE Amerisyn, LLC 5680d373-0f61-baf8-e063-6394a90ab8a6 2026-07-13 Warnings, Adverse reactions Exact identifier application applno (ANDA): 074823 application number: ANDA074823 Terazosin Hydrochloride TERAZOSIN HYDROCHLORIDE Amici Pharma, Inc. 4007dbd3-e850-43e7-8a56-8735e31063cd 2026-05-20 Warnings, Adverse reactions Exact identifier application applno (ANDA): 074823 application number: ANDA074823 Terazosin Hydrochloride TERAZOSIN HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 214d9b06-8d23-3ee8-e063-6394a90a1521 2024-09-04 Warnings, Adverse reactions Exact identifier application applno (ANDA): 074823 application number: ANDA074823 ndc (product): 71610-854 Terazosin Hydrochloride TERAZOSIN HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 9199083d-403f-4c9e-90e1-713ed0a07903 2023-04-05 Warnings, Adverse reactions Exact identifier application applno (ANDA): 074823 application number: ANDA074823 Terazosin Hydrochloride TERAZOSIN HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC e5507ea6-bdb3-4363-a68b-0478cbb25f4a 2021-08-26 Warnings, Adverse reactions Exact identifier application applno (ANDA): 074823 application number: ANDA074823
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71610-854-30 71610085430 30 CAPSULE in 1 BOTTLE (71610-854-30) 30 capsule 2024-09-03 No No Current 71610-854-53 71610085453 60 CAPSULE in 1 BOTTLE (71610-854-53) 60 capsule 2024-09-03 No No Current 71610-854-60 71610085460 90 CAPSULE in 1 BOTTLE (71610-854-60) 90 capsule 2024-09-03 No No Current 71610-854-80 71610085480 180 CAPSULE in 1 BOTTLE (71610-854-80) 180 capsule 2024-09-03 No No Current