Terazosin Hydrochloride

Product NDC: 71610-594
11-digit product format: 716100594
Labeler code: 71610
Product ID: 71610-594_2b26376c-c9c8-4d68-aec5-f3aa773fe7f9
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: 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 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	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.

Application-product, TE code table
Application-product	TE code
A074823-001	AB
A074823-002	AB
A074823-003	AB
A074823-004	AB

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074823-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074823-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074823-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074823-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074823-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074823-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074823-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074823-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074823-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074823-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074823-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074823-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074823-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074823-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074823-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074823-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074823-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074823-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074823-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074823-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074823-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074823-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074823-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074823-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074823-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074823-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074823-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074823-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074823-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074823-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074823-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074823-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074823-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074823-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074823-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074823-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074823-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074823-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074823-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074823-004	AB	1	`d06236e962d9…`

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	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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
260376	Internal RxNorm lookup
313219	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e5507ea6-bdb3-4363-a68b-0478cbb25f4a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
975cd6e7-95ee-60f8-7c38-135ffbb09240	Product name	2	20260223
1bc6d1ac-ef0f-4fc6-8704-c443f03b274a	Product name	1	20250311
8adc9826-3fee-6091-f1ee-af9fd6f9caf8	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71610-594-60	Terazosin Hydrochloride	90 in 1 BOTTLE	CAPSULE	90		1
71610-594-80	Terazosin Hydrochloride	180 in 1 BOTTLE	CAPSULE	180		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-594-60	EA - Each	71610-594	e081cac5-4b69-4425-9a8d-3013b05c0cec	1	2021-10-08
71610-594-80	EA - Each	71610-594	445a72c4-d921-4189-a23d-1bcc9c050af3	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-594	TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Current NDC, Legacy NDC, 2 package rows	20210829_e5507ea6-bdb3-4363-a68b-0478cbb25f4a.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
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 ndc (product): 71610-594

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D32S14F082	TERAZOSIN HYDROCHLORIDE	70024-40-7	TERAZOSIN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
260376	terazosin HCl 10 MG Oral Capsule	PSN	e5507ea6-bdb3-4363-a68b-0478cbb25f4a	1
313219	terazosin HCl 5 MG Oral Capsule	PSN	e5507ea6-bdb3-4363-a68b-0478cbb25f4a	1
260376	terazosin 10 MG Oral Capsule	SCD	e5507ea6-bdb3-4363-a68b-0478cbb25f4a	1
313219	terazosin 5 MG Oral Capsule	SCD	e5507ea6-bdb3-4363-a68b-0478cbb25f4a	1
260376	terazosin (as terazosin HCl) 10 MG Oral Capsule	SY	e5507ea6-bdb3-4363-a68b-0478cbb25f4a	1
313219	terazosin (as terazosin hydrochloride) 5 MG Oral Capsule	SY	e5507ea6-bdb3-4363-a68b-0478cbb25f4a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-594-60	71610059460	90 CAPSULE in 1 BOTTLE (71610-594-60)	90 capsule	2021-08-26	0000-00-00	No	No	Current
71610-594-80	71610059480	180 CAPSULE in 1 BOTTLE (71610-594-80)	180 capsule	2021-08-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Terazosin Capsules, USP	Aphena Pharma Solutions - Tennessee, LLC	2021-08-26	HUMAN PRESCRIPTION DRUG LABEL	1