Prazosin Hydrochloride

Product NDC: 67046-1678
11-digit product format: 670461678
Labeler code: 67046
Product ID: 67046-1678_52ce0743-6b88-a3a5-e063-6294a90a5783
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prazosin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Coupler LLC
Application: ANDA213052
Marketing category: ANDA
Marketing start: 2026-05-27
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: 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A213052-001	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2023-03-31
A213052-002	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2023-03-31
A213052-003	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2023-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213052-001	AB
A213052-002	AB
A213052-003	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 2 · 75 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	A213052-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2023-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213052-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2023-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213052-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2023-03-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213052-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2023-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213052-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2023-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213052-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2023-03-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213052-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2023-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213052-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2023-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213052-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2023-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213052-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2023-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213052-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2023-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213052-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2023-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213052-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2023-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213052-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2023-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213052-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2023-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213052-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2023-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213052-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2023-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213052-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2023-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213052-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2023-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213052-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2023-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213052-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2023-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213052-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2023-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213052-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2023-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213052-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2023-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213052-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2023-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213052-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2023-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213052-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2023-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213052-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2023-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213052-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2023-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213052-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2023-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213052-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2023-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213052-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2023-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213052-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2023-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213052-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2023-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213052-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2023-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213052-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2023-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213052-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2023-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213052-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2023-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213052-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2023-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213052-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2023-03-31	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 75 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	A213052-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213052-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213052-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213052-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213052-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213052-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213052-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213052-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213052-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213052-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213052-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213052-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213052-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213052-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213052-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213052-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213052-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213052-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213052-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213052-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213052-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213052-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213052-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213052-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213052-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213052-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213052-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213052-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213052-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213052-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213052-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213052-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213052-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213052-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213052-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213052-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213052-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213052-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213052-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213052-001	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: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198141	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
52ce82b0-3cb5-b5b2-e063-6394a90a9f12	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
67046-1678-3	Prazosin Hydrochloride	30 in 1 BLISTER PACK	CAPSULE	30		1

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
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Unit Dose Solutions, Inc.	558ea3fc-0bfc-32a0-e063-6294a90ae106	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213052 application number: ANDA213052
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Unit Dose Solutions, Inc.	559082c2-4130-a2bc-e063-6294a90ab781	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213052 application number: ANDA213052
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Coupler LLC	52ce82b0-3cb5-b5b2-e063-6394a90a9f12	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213052 application number: ANDA213052 ndc (product): 67046-1678
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4870ed0b-abde-5ae5-e063-6394a90ad0ba	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213052 application number: ANDA213052
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Aurobindo Pharma Limited	08114092-fa12-4f58-b08e-03cadf9f726b	2023-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213052 application number: ANDA213052

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
198141	prazosin HCl 5 MG Oral Capsule	PSN	52ce82b0-3cb5-b5b2-e063-6394a90a9f12	1
198141	prazosin 5 MG Oral Capsule	SCD	52ce82b0-3cb5-b5b2-e063-6394a90a9f12	1
198141	prazosin (as prazosin HCl) 5 MG Oral Capsule	SY	52ce82b0-3cb5-b5b2-e063-6394a90a9f12	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-1678-3	67046167803	30 CAPSULE in 1 BLISTER PACK (67046-1678-3)	30 capsule	2026-05-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prazosin Hydrochloride Capsules USP For Oral Use Rx only	Coupler LLC	2026-05-27	HUMAN PRESCRIPTION DRUG LABEL	1