Terazosin

Product NDC: 42291-823
Requested package NDC: 42291-823-10
11-digit product format: 422910823
Labeler code: 42291
Product ID: 42291-823_3a9ec205-cdb5-e131-e063-6294a90acb60
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Terazosin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: AvKARE
Application: ANDA075317
Marketing category: ANDA
Marketing start: 2020-03-30
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	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 · 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	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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075317-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	RS	2004-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075317-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2004-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075317-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB		2004-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075317-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		2004-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075317-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	RS	2004-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075317-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2004-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075317-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB		2004-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075317-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		2004-12-20	`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	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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075317-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075317-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075317-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075317-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075317-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075317-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075317-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075317-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Terazosin
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 · 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
a2137488-8554-e84f-e053-2995a90a796c	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
42291-823-10	Terazosin	1000 in 1 BOTTLE	CAPSULE	1000		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-823-10	EA - Each	42291-823	f7945fc0-506b-4f5a-a6dd-5b20b4a55bd6	1	2020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-823	TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [AVKARE]	3	Current NDC, Legacy NDC, 1 package rows	20241010_a2137488-8554-e84f-e053-2995a90a796c.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 · 26 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	A-S Medication Solutions	83bf40fa-6ae1-4811-8dc1-e8c0bcd63d78	2026-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075317 application number: ANDA075317
Terazosin	TERAZOSIN HYDROCHLORIDE	REMEDYREPACK INC.	854b64ff-c138-45af-9cdf-6c23323d8490	2026-01-08	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 ndc (package): 42291-823-10 ndc (product): 42291-823 ndc11 (package): 42291082310
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

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	a2137488-8554-e84f-e053-2995a90a796c	4
260376	terazosin HCl 10 MG Oral Capsule	PSN	a2137488-8554-e84f-e053-2995a90a796c	4
313217	terazosin HCl 2 MG Oral Capsule	PSN	a2137488-8554-e84f-e053-2995a90a796c	4
313219	terazosin HCl 5 MG Oral Capsule	PSN	a2137488-8554-e84f-e053-2995a90a796c	4
313215	terazosin 1 MG Oral Capsule	SCD	a2137488-8554-e84f-e053-2995a90a796c	4
260376	terazosin 10 MG Oral Capsule	SCD	a2137488-8554-e84f-e053-2995a90a796c	4
313217	terazosin 2 MG Oral Capsule	SCD	a2137488-8554-e84f-e053-2995a90a796c	4
313219	terazosin 5 MG Oral Capsule	SCD	a2137488-8554-e84f-e053-2995a90a796c	4
313215	terazosin (as terazosin HCl) 1 MG Oral Capsule	SY	a2137488-8554-e84f-e053-2995a90a796c	4
260376	terazosin (as terazosin HCl) 10 MG Oral Capsule	SY	a2137488-8554-e84f-e053-2995a90a796c	4
313217	terazosin (as terazosin HCl) 2 MG Oral Capsule	SY	a2137488-8554-e84f-e053-2995a90a796c	4
313219	terazosin (as terazosin hydrochloride) 5 MG Oral Capsule	SY	a2137488-8554-e84f-e053-2995a90a796c	4
260376	terazosin HCl 10 MG Oral Capsule	PSN	d979b574-814a-4da1-86af-6a205ffe4683	1
260376	terazosin 10 MG Oral Capsule	SCD	d979b574-814a-4da1-86af-6a205ffe4683	1
260376	terazosin (as terazosin HCl) 10 MG Oral Capsule	SY	d979b574-814a-4da1-86af-6a205ffe4683	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42291-823-10	42291082310	1000 CAPSULE in 1 BOTTLE (42291-823-10)	1000 capsule	2020-03-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TERAZOSIN CAPSULES, USP Rx Only	AvKARE	2025-07-23	HUMAN PRESCRIPTION DRUG LABEL	4
TERAZOSIN CAPSULES, USP Rx Only	Aphena Pharma Solutions - Tennessee, LLC	2020-05-24	HUMAN PRESCRIPTION DRUG LABEL	1