prazosin hydrochloride

Product NDC: 67046-1050
11-digit product format: 670461050
Labeler code: 67046
Product ID: 67046-1050_583b4ab6-2fce-bd63-e063-6394a90ae657
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: prazosin hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Coupler LLC
Application: ANDA215697
Marketing category: ANDA
Marketing start: 2026-08-04
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
A215697-001	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30
A215697-002	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30
A215697-003	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215697-001	AB
A215697-002	AB
A215697-003	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 · 78 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	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 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	A215697-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215697-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215697-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215697-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215697-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215697-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215697-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215697-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215697-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215697-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215697-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215697-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215697-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215697-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215697-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215697-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215697-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215697-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215697-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215697-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215697-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215697-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215697-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215697-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215697-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215697-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215697-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215697-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215697-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215697-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215697-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215697-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215697-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215697-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215697-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215697-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215697-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215697-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215697-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215697-001	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
583b4b06-71e4-4696-e063-6294a90a15bf	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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	REMEDYREPACK INC.	e4852fc2-b763-40e2-b8bb-a3f6da5c72fe	2026-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	e5bd5728-ea7c-4f16-832b-8d58fe14b994	2026-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	REMEDYREPACK INC.	95aa9ffb-66bb-4049-a241-0e1166b4c264	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	REMEDYREPACK INC.	8606d9b8-4529-4689-8c93-7114c84c2e54	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Coupler LLC	583b4b06-71e4-4696-e063-6294a90a15bf	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697 ndc (product): 67046-1050
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	ASCLEMED USA INC.	b66d105b-be78-4e54-9c01-b38e36ad74de	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	fa00e99e-f050-4544-a11b-d20c9710761e	2025-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	35a996a5-abba-838d-e063-6294a90a72a4	2025-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	35a9c70d-b611-cf9d-e063-6294a90a23f7	2025-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Coupler, LLC	30b70064-79e1-b8a9-e063-6394a90a69cb	2025-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
Prazosin HCL	PRAZOSIN HCL	Direct_Rx	fb6db16d-3768-631b-e053-6294a90a1cee	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	f8fd7e1d-471d-f4ae-e053-6294a90a8b41	2024-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
Prazosin HCL	PRAZOSIN HCL	Direct_Rx	f6c9eef9-c016-9020-e053-6294a90a1cd8	2024-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
Prazosin HCL	PRAZOSIN HCL	Direct_Rx	13018fa7-5e30-ed92-e063-6394a90a4427	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Proficient Rx LP	2a928735-179f-4637-8c4e-3b5e01d45bf2	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	61e5108a-70eb-4d48-a742-defb2e918b63	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	f475c5e7-94df-40c8-b35f-ce6f866ed1b9	2023-12-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Proficient Rx LP	b8a9cbee-c526-4d1e-ad2f-cf7fbb784936	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Lifestar Pharma LLC	73bbc360-5bfb-4139-a63e-0cb6e4ea8313	2023-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-1050-3	67046105003	30 CAPSULE in 1 BLISTER PACK (67046-1050-3)	30 capsule	2026-08-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prazosin Hydrochloride Capsules, USP	Coupler LLC \| Mankind Pharma Limited	2026-08-04	HUMAN PRESCRIPTION DRUG LABEL	1