Terazosin hydrochloride

Product NDC: 67544-562
Requested package NDC: 67544-562-53
11-digit product format: 675440562
Labeler code: 67544
Product ID: 67544-562_004a3e21-609c-4b46-8628-be2d8599608e
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
Marketing end: 0000-00-00
Substance: TERAZOSIN HYDROCHLORIDE
Active strength: 2 mg/1
Pharmacologic classes: Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67544-562	67544-562-53	I	Inactivated by FDA		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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.

Application-product, TE code table
Application-product	TE code
A075317-001	AB
A075317-002	AB
A075317-003	AB
A075317-004	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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075317-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075317-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075317-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075317-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075317-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075317-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075317-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075317-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075317-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075317-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075317-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075317-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075317-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075317-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075317-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075317-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075317-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075317-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075317-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075317-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075317-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075317-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075317-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075317-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075317-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075317-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075317-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075317-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075317-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075317-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075317-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075317-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075317-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075317-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075317-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075317-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075317-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075317-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075317-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075317-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
67544-562-30	TERAZOSIN CAPSULES, USP
67544-562-53	TERAZOSIN CAPSULES, USP
67544-562-60	TERAZOSIN CAPSULES, USP
67544-562-70	TERAZOSIN CAPSULES, USP
67544-562-80	TERAZOSIN CAPSULES, USP
67544-562-92	TERAZOSIN CAPSULES, USP
67544-562-94	TERAZOSIN CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67544-562-30	Terazosin hydrochloride	30 in 1 BOTTLE, PLASTIC	CAPSULE	30	3
67544-562-53	Terazosin hydrochloride	60 in 1 BOTTLE, PLASTIC	CAPSULE	60	3
67544-562-60	Terazosin hydrochloride	90 in 1 BOTTLE, PLASTIC	CAPSULE	90	3
67544-562-70	Terazosin hydrochloride	120 in 1 BOTTLE, PLASTIC	CAPSULE	120	3
67544-562-80	Terazosin hydrochloride	180 in 1 BOTTLE, PLASTIC	CAPSULE	180	3
67544-562-92	Terazosin hydrochloride	270 in 1 BOTTLE, PLASTIC	CAPSULE	270	3
67544-562-94	Terazosin hydrochloride	360 in 1 BOTTLE, PLASTIC	CAPSULE	360	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67544-562-30	EA - Each	67544-562	c2e0c209-8572-4b50-bf52-b875c5248e7e	1	2013-02-13
67544-562-53	EA - Each	67544-562	d1036228-8030-44ba-882a-bfa7268ff817	1	2013-02-13
67544-562-60	EA - Each	67544-562	b4868b9d-50f2-44b2-83b0-dab4ee09161e	1	2013-02-13
67544-562-70	EA - Each	67544-562	d1316e05-8edd-49e3-ab24-e2f84b53c6a5	1	2013-02-13
67544-562-80	EA - Each	67544-562	ca9846ba-fd49-492a-a078-3bfe1571eb53	1	2013-02-13
67544-562-92	EA - Each	67544-562	86a32c2d-d11a-4776-a3e5-34cbeb398f54	1	2013-02-13
67544-562-94	EA - Each	67544-562	975c69a1-4f0a-4313-9a14-ebef17ae71f7	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Terazosin Hydrochloride	ACTIVE INGREDIENT	D32S14F082	TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Terazosin	ACTIVE MOIETY	8L5014XET7	TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
D&c Red No. 28	INACTIVE INGREDIENT	767IP0Y5NH	TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
D&c Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Fd&c Green No. 3	INACTIVE INGREDIENT	3P3ONR6O1S	TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Fd&c Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Ferrosoferric Oxide	INACTIVE INGREDIENT	XM0M87F357	TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Gelatin	INACTIVE INGREDIENT	2G86QN327L	TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67544-562	TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3	Legacy NDC, 7 package rows	20191224_21c6bec7-4767-4113-8561-38497dae50d0.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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Terazosin	TERAZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	458b4a60-b2d6-445a-8638-7fcd07decf66	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075317 application number: ANDA075317
Terazosin	TERAZOSIN HYDROCHLORIDE	REMEDYREPACK INC.	a3a5901a-6395-4030-a27b-1fb17cd97315	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075317 application number: ANDA075317
Terazosin	TERAZOSIN HYDROCHLORIDE	REMEDYREPACK INC.	242589f0-0c79-4ea1-b900-10bccfec2b82	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075317 application number: ANDA075317
Terazosin	TERAZOSIN HYDROCHLORIDE	Jubilant Cadista Pharmaceuticals Inc.	43e92495-2cf2-46dd-a80c-f0c3c88c7b73	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075317 application number: ANDA075317
TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	2c42171e-1b44-4d34-b6ca-5b6a94f0e694	2026-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075317 application number: ANDA075317
Terazosin Hydrochloride	TERAZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	d971811c-d327-4e63-808c-8d553ee471e7	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075317 application number: ANDA075317
Terazosin	TERAZOSIN HYDROCHLORIDE	Coupler LLC	4614e8cc-c922-4c0f-e063-6394a90a8501	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075317 application number: ANDA075317
Terazosin	TERAZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	3822068f-f160-4493-a207-4d75dad6af73	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075317 application number: ANDA075317
Terazosin	TERAZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	bb88f0d9-e010-4d4d-8465-bcccce0bef6e	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075317 application number: ANDA075317
Terazosin hydrochloride	TERAZOSIN HYDROCHLORIDE	Preferred Pharmaceuticals, Inc	9d8fd052-b478-447e-a884-74fcd21275bb	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075317 application number: ANDA075317
Terazosin	TERAZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	521e4aad-c6ec-4410-867f-dd9ecc08d5b2	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075317 application number: ANDA075317
Terazosin	TERAZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	33699a94-4561-455f-9e5d-48856369aa07	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075317 application number: ANDA075317
Terazosin	TERAZOSIN HYDROCHLORIDE	AvKARE	a2137488-8554-e84f-e053-2995a90a796c	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075317 application number: ANDA075317
Terazosin	TERAZOSIN HYDROCHLORIDE	AvPAK	9e7b27a6-cc09-407e-e053-2a95a90a17b3	2025-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075317 application number: ANDA075317
Terazosin	TERAZOSIN HYDROCHLORIDE	A-S Medication Solutions	4b195327-10d4-477f-ada2-d62c7f835e6c	2024-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075317 application number: ANDA075317
Terazosin	TERAZOSIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	40e5ae44-708a-15a3-e054-00144ff8d46c	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075317 application number: ANDA075317
Terazosin	TERAZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	363a6c85-e5e9-4521-9065-37a7c45bb525	2024-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075317 application number: ANDA075317
Terazosin	TERAZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	85e450c2-1bc3-49f4-ac2b-5aeedc154bba	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075317 application number: ANDA075317
Terazosin	TERAZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	0574d9ae-04da-4cb2-b124-9d920012c411	2023-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075317 application number: ANDA075317
Terazosin	TERAZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	2f2db826-182d-4dd1-af97-f874b57b1fb9	2023-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075317 application number: ANDA075317

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
313215	terazosin HCl 1 MG Oral Capsule	PSN	21c6bec7-4767-4113-8561-38497dae50d0	3
260376	terazosin HCl 10 MG Oral Capsule	PSN	21c6bec7-4767-4113-8561-38497dae50d0	3
313217	terazosin HCl 2 MG Oral Capsule	PSN	21c6bec7-4767-4113-8561-38497dae50d0	3
313219	terazosin HCl 5 MG Oral Capsule	PSN	21c6bec7-4767-4113-8561-38497dae50d0	3
313215	terazosin 1 MG Oral Capsule	SCD	21c6bec7-4767-4113-8561-38497dae50d0	3
260376	terazosin 10 MG Oral Capsule	SCD	21c6bec7-4767-4113-8561-38497dae50d0	3
313217	terazosin 2 MG Oral Capsule	SCD	21c6bec7-4767-4113-8561-38497dae50d0	3
313219	terazosin 5 MG Oral Capsule	SCD	21c6bec7-4767-4113-8561-38497dae50d0	3
313215	terazosin (as terazosin HCl) 1 MG Oral Capsule	SY	21c6bec7-4767-4113-8561-38497dae50d0	3
260376	terazosin (as terazosin HCl) 10 MG Oral Capsule	SY	21c6bec7-4767-4113-8561-38497dae50d0	3
313217	terazosin (as terazosin HCl) 2 MG Oral Capsule	SY	21c6bec7-4767-4113-8561-38497dae50d0	3
313219	terazosin (as terazosin hydrochloride) 5 MG Oral Capsule	SY	21c6bec7-4767-4113-8561-38497dae50d0	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67544-562-53	67544056253	60 CAPSULE in 1 BOTTLE, PLASTIC (67544-562-53)	60 capsule	2006-05-20	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	2019-12-23	HUMAN PRESCRIPTION DRUG LABEL	3