Prazosin Hydrochloride

Product NDC: 76282-723
Requested package NDC: 76282-723-01
11-digit product format: 762820723
Labeler code: 76282
Product ID: 76282-723_f3388e9a-2c36-de8d-e053-2a95a90aa213
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prazosin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Exelan Pharmaceuticals
Application: ANDA214608
Marketing category: ANDA
Marketing start: 2023-01-17
Substance: PRAZOSIN HYDROCHLORIDE
Active strength: 5 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 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214608-001	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2021-12-23
A214608-002	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2021-12-23
A214608-003	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2021-12-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A214608-001	AB
A214608-002	AB
A214608-003	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 3 · 102 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	A214608-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2021-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214608-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2021-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214608-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2021-12-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214608-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2021-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214608-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2021-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214608-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2021-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214608-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2021-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214608-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2021-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214608-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2021-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214608-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2021-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214608-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2021-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214608-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2021-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214608-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2021-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214608-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2021-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214608-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2021-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214608-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2021-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214608-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2021-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214608-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2021-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214608-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2021-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214608-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2021-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214608-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2021-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214608-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2021-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214608-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2021-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214608-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2021-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214608-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2021-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214608-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2021-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214608-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2021-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214608-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2021-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214608-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2021-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214608-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2021-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214608-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2021-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214608-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2021-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214608-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2021-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214608-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2021-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214608-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2021-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214608-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2021-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214608-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2021-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214608-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2021-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214608-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2021-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214608-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2021-12-23	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 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	A214608-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214608-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214608-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214608-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214608-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214608-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214608-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214608-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214608-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214608-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214608-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214608-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214608-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214608-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214608-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214608-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214608-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214608-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214608-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214608-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214608-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214608-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214608-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214608-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214608-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214608-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214608-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214608-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214608-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214608-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214608-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214608-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214608-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214608-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214608-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214608-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214608-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214608-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214608-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214608-001	AB	1	`301d65b070ca…`

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: Prazosin Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRAZOSIN 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
X0Z7454B90	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198141	Internal RxNorm lookup
312593	Internal RxNorm lookup
312594	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
cdde7b22-6b29-4cac-8bd6-f613dab6eef1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5a3de99-75de-4527-38ae-07b1328b93cb	Product name	5	20250331

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76282-723-01	Prazosin Hydrochloride	100 in 1 BOTTLE	CAPSULE	100		2
76282-723-25	Prazosin Hydrochloride	250 in 1 BOTTLE	CAPSULE	250		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76282-723-01	EA - Each	76282-723	6c6208a9-a420-4558-ae7f-af7a0be4ebc9	1	2023-02-06
76282-723-25	EA - Each	76282-723	86d1c157-32ef-4522-aec5-77b94682f3fb	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76282-723	PRAZOSIN HYDROCHLORIDE CAPSULE [EXELAN PHARMACEUTICALS]	2	Current NDC, 2 package rows	20230129_cdde7b22-6b29-4cac-8bd6-f613dab6eef1.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Granules Pharmaceuticals Inc.	d01b8927-a422-43b3-89de-088506fdee3c	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214608 application number: ANDA214608
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	18680157-a123-1072-e063-6394a90ad5ef	2024-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214608 application number: ANDA214608
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	d33bb132-1b5f-44a2-bc42-e9201cb6566a	2023-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214608 application number: ANDA214608
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Exelan Pharmaceuticals	cdde7b22-6b29-4cac-8bd6-f613dab6eef1	2023-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214608 application number: ANDA214608 ndc (package): 76282-723-01 ndc (product): 76282-723 ndc11 (package): 76282072301

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X0Z7454B90	PRAZOSIN HYDROCHLORIDE	19237-84-4	PRAZOSIN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312593	prazosin HCl 1 MG Oral Capsule	PSN	cdde7b22-6b29-4cac-8bd6-f613dab6eef1	2
312594	prazosin HCl 2 MG Oral Capsule	PSN	cdde7b22-6b29-4cac-8bd6-f613dab6eef1	2
198141	prazosin HCl 5 MG Oral Capsule	PSN	cdde7b22-6b29-4cac-8bd6-f613dab6eef1	2
312593	prazosin 1 MG Oral Capsule	SCD	cdde7b22-6b29-4cac-8bd6-f613dab6eef1	2
312594	prazosin 2 MG Oral Capsule	SCD	cdde7b22-6b29-4cac-8bd6-f613dab6eef1	2
198141	prazosin 5 MG Oral Capsule	SCD	cdde7b22-6b29-4cac-8bd6-f613dab6eef1	2
312593	prazosin (as prazosin HCl) 1 MG Oral Capsule	SY	cdde7b22-6b29-4cac-8bd6-f613dab6eef1	2
312594	prazosin (as prazosin HCl) 2 MG Oral Capsule	SY	cdde7b22-6b29-4cac-8bd6-f613dab6eef1	2
198141	prazosin (as prazosin HCl) 5 MG Oral Capsule	SY	cdde7b22-6b29-4cac-8bd6-f613dab6eef1	2
198141	prazosin HCl 5 MG Oral Capsule	PSN	18680157-a123-1072-e063-6394a90ad5ef	1
198141	prazosin 5 MG Oral Capsule	SCD	18680157-a123-1072-e063-6394a90ad5ef	1
198141	prazosin (as prazosin HCl) 5 MG Oral Capsule	SY	18680157-a123-1072-e063-6394a90ad5ef	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76282-723-01	76282072301	100 CAPSULE in 1 BOTTLE (76282-723-01)	100 capsule	2023-01-17	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prazosin Hydrochloride Capsules, USP.	Aphena Pharma Solutions - Tennessee, LLC	2024-05-14	HUMAN PRESCRIPTION DRUG LABEL	1
Prazosin Hydrochloride Capsules, USP.	Exelan Pharmaceuticals	2023-01-26	HUMAN PRESCRIPTION DRUG LABEL	2