terazosin

Product NDC: 53401-022
11-digit product format: 534010022
Labeler code: 53401
Product ID: 53401-022_57125b47-2157-181c-e063-6394a90ad763
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: terazosin
Dosage form: CAPSULE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA075614
Marketing category: ANDA
Marketing start: 2021-04-30
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: 2027-12-31
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	Approval date
A075614-001	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2001-01-30
A075614-002	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2001-01-30
A075614-003	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2001-01-30
A075614-004	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2001-01-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A075614-001	AB
A075614-002	AB
A075614-003	AB
A075614-004	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 · 172 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
2026-09-14 22:38:34	2026-08	A075614-001	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2001-01-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075614-002	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2001-01-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075614-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2001-01-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075614-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2001-01-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075614-001	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2001-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075614-002	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2001-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075614-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2001-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075614-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2001-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075614-001	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2001-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075614-002	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2001-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075614-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2001-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075614-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2001-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075614-001	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2001-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075614-002	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2001-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075614-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2001-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075614-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2001-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075614-001	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2001-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075614-002	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2001-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075614-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2001-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075614-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2001-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075614-001	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2001-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075614-002	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2001-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075614-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2001-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075614-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2001-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075614-001	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2001-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075614-002	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2001-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075614-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2001-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075614-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2001-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075614-001	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2001-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075614-002	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2001-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075614-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2001-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075614-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2001-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075614-001	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2001-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075614-002	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2001-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075614-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2001-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075614-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2001-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075614-001	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2001-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075614-002	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2001-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075614-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2001-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075614-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2001-01-30	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 156 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075614-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075614-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075614-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075614-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075614-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075614-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075614-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075614-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075614-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075614-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075614-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075614-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075614-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075614-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075614-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075614-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075614-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075614-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075614-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075614-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075614-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075614-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075614-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075614-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075614-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075614-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075614-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075614-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075614-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075614-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075614-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075614-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075614-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075614-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075614-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075614-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075614-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075614-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075614-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075614-004	AB	1	`5bbf6a4d5a75…`

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: 2027-12-31

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
57125b47-2156-181c-e063-6394a90ad763	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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
terazosin	TERAZOSIN	Aphena Pharma Solutions - Tennessee, LLC	57125b47-2156-181c-e063-6394a90ad763	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075614 application number: ANDA075614 ndc (product): 53401-022
terazosin	TERAZOSIN	REMEDYREPACK INC.	77e01f71-f6d8-4bbe-b13e-352c7af6b1ef	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075614 application number: ANDA075614
terazosin	TERAZOSIN	A-S Medication Solutions	916cf0fa-8e39-4b4d-b564-a16aa8511ff6	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075614 application number: ANDA075614
terazosin	TERAZOSIN	Northwind Health Company, LLC	ff0efbc2-d7aa-9783-e053-6394a90a384f	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075614 application number: ANDA075614
Terazosin	TERAZOSIN	Chartwell RX, LLC	da4ca0f8-6888-447e-9948-d37196c5a19a	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075614 application number: ANDA075614
terazosin	TERAZOSIN	Preferred Pharmaceuticals Inc.	a78f74ce-1c53-41ea-878e-13674db10a67	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075614 application number: ANDA075614
terazosin	TERAZOSIN	Bryant Ranch Prepack	2cdbb03d-0ac9-477b-88f6-5d9492277048	2023-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075614 application number: ANDA075614
terazosin	TERAZOSIN	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	1dabd4d6-3023-460a-8577-08b3690e7c93	2021-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075614 application number: ANDA075614

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D32S14F082	TERAZOSIN HYDROCHLORIDE	70024-40-7	TERAZOSIN HYDROCHLORIDE
8L5014XET7	TERAZOSIN	63590-64-7	terazosin

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
53401-022-53	53401002253	60 CAPSULE in 1 BOTTLE (53401-022-53)	60 capsule	2026-07-20	No	No	Current
53401-022-60	53401002260	90 CAPSULE in 1 BOTTLE (53401-022-60)	90 capsule	2026-07-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Terazosin Capsules, USP	Aphena Pharma Solutions - Tennessee, LLC	2026-07-20	HUMAN PRESCRIPTION DRUG LABEL	1