Prazosin Hydrochloride

Product NDC: 48433-086
11-digit product format: 484330086
Labeler code: 48433
Product ID: 48433-086_4f0c392d-3ce9-d8e7-e063-6294a90a2005
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: prazosin hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Safecor Health LLC
Application: ANDA072575
Marketing category: ANDA
Marketing start: 2026-03-25
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 42.

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
A072575-001	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16
A072575-002	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16
A072575-003	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072575-001	AB
A072575-002	AB
A072575-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072575-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1989-05-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072575-003	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1989-05-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072575-001	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1989-05-16	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A072575-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072575-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072575-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072575-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072575-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072575-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072575-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072575-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072575-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072575-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072575-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072575-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072575-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072575-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072575-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072575-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072575-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072575-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072575-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072575-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072575-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072575-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072575-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072575-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072575-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072575-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072575-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072575-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072575-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072575-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072575-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072575-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072575-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072575-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072575-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072575-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072575-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072575-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072575-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072575-001	AB	1	`1e350fbaab3a…`

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 · 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
12cdde5b-173c-4f31-a326-3128d521930c	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
48433-086-01	Prazosin Hydrochloride	1 in 1 BLISTER PACK	CAPSULE	1		2
48433-086-20	Prazosin Hydrochloride	100 in 1 CARTON	CAPSULE	100		2

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	REMEDYREPACK INC.	39e3fa5d-ea48-4b02-80f6-44591f5e013f	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072575 application number: ANDA072575
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Safecor Health LLC	12cdde5b-173c-4f31-a326-3128d521930c	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072575 application number: ANDA072575 ndc (product): 48433-086
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	e5e129aa-2ee3-4c12-a327-5d5382cf2310	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072575 application number: ANDA072575
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	5d7dff44-84b1-4044-bc5a-c76ea11dd5a3	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072575 application number: ANDA072575
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	cd52f022-ca29-4f87-8684-da63e05b3c1f	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072575 application number: ANDA072575
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Mylan Institutional Inc.	e6a029b2-802f-4cc5-8795-20e177e8d779	2025-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072575 application number: ANDA072575
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	1a92a503-cf5e-48ef-a6fd-79fe98fdd8a0	2023-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072575 application number: ANDA072575
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	1ce90aaf-d075-4617-9a47-e8d922096d23	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072575 application number: ANDA072575

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	12cdde5b-173c-4f31-a326-3128d521930c	2
312594	prazosin HCl 2 MG Oral Capsule	PSN	12cdde5b-173c-4f31-a326-3128d521930c	2
198141	prazosin HCl 5 MG Oral Capsule	PSN	12cdde5b-173c-4f31-a326-3128d521930c	2
312593	prazosin 1 MG Oral Capsule	SCD	12cdde5b-173c-4f31-a326-3128d521930c	2
312594	prazosin 2 MG Oral Capsule	SCD	12cdde5b-173c-4f31-a326-3128d521930c	2
198141	prazosin 5 MG Oral Capsule	SCD	12cdde5b-173c-4f31-a326-3128d521930c	2
312593	prazosin (as prazosin HCl) 1 MG Oral Capsule	SY	12cdde5b-173c-4f31-a326-3128d521930c	2
312594	prazosin (as prazosin HCl) 2 MG Oral Capsule	SY	12cdde5b-173c-4f31-a326-3128d521930c	2
198141	prazosin (as prazosin HCl) 5 MG Oral Capsule	SY	12cdde5b-173c-4f31-a326-3128d521930c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
48433-086-01	48433008601	1 in 1 BLISTER PACK					Historical
48433-086-20	48433008620	100 BLISTER PACK in 1 CARTON (48433-086-20) / 1 CAPSULE in 1 BLISTER PACK (48433-086-01)	100 blister pack	2026-03-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prazosin Hydrochloride - Safecor Health LLC	Safecor Health LLC	2026-04-09	HUMAN PRESCRIPTION DRUG LABEL	2