Terazosin Hydrochloride

Product NDC: 87564-008
Requested package NDC: 87564-008-01
11-digit product format: 875640008
Labeler code: 87564
Product ID: 87564-008_5680d373-0f60-baf8-e063-6394a90ab8a6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Terazosin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Amerisyn, LLC
Application: ANDA074823
Marketing category: ANDA
Marketing start: 2026-07-01
Substance: TERAZOSIN HYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: Adrenergic alpha-Antagonists [MoA]; alpha-Adrenergic Blocker [EPC]
Listing certified through: 2027-12-31
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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TERAZOSIN HYDROCHLORIDE	5 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
260376	Internal RxNorm lookup
313215	Internal RxNorm lookup
313217	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
5680d373-0f61-baf8-e063-6394a90ab8a6	Available on FDA.report

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 ndc (package): 87564-008-01 ndc (product): 87564-008 ndc11 (package): 87564000801
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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Status
87564-008-01	87564000801	1000 CAPSULE in 1 BOTTLE (87564-008-01)	1000 capsule	2026-07-01	0	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Terazosin Capsules, USP	Amerisyn, LLC \| Havix Group Inc d/b/a Aavis Pharmaceuticals	2026-07-13	HUMAN PRESCRIPTION DRUG LABEL	1