Prazosin Hydrochloride

Product NDC: 68788-8144
11-digit product format: 687888144
Labeler code: 68788
Product ID: 68788-8144_58b9fbe4-4e70-4525-86e8-4e3e8ab30e62
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prazosin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA214608
Marketing category: ANDA
Marketing start: 2022-02-15
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68788-8144		D	Discontinued by firm		2026-08-07
excluded package	package	68788-8144	68788-8144-3	D	Discontinued by firm		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	68788-8144		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-8144	68788-8144-3	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 96 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
2026-02-19 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214608-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2021-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214608-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2021-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214608-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2021-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214608-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2021-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214608-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2021-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214608-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2021-12-23	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 96 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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214608-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214608-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214608-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214608-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214608-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214608-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8144-3	EA - Each	68788-8144	2f4d17d0-beca-40bc-bd67-039cf4ef2998	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8144	PRAZOSIN HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]	3	Legacy NDC	20240802_58b9fbe4-4e70-4525-86e8-4e3e8ab30e62.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

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	Marketing end	Sample	Exclude flag	Status
68788-8144-3	68788814403	30 CAPSULE in 1 BOTTLE (68788-8144-3)	30 capsule	2022-02-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prazosin Hydrochloride Capsules, USP.	Preferred Pharmaceuticals Inc.	2024-07-31	HUMAN PRESCRIPTION DRUG LABEL	3