Prazosin Hydrochloride

Product NDC: 70518-2178
11-digit product format: 705182178
Labeler code: 70518
Product ID: 70518-2178_49dae439-65b6-e69b-e063-6294a90a3992
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prazosin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA210971
Marketing category: ANDA
Marketing start: 2019-07-01
Substance: PRAZOSIN HYDROCHLORIDE
Active strength: 2 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

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 package	package	70518-2178	70518-2178-0	D	Discontinued by firm		2026-08-17
excluded package	package	70518-2178	70518-2178-1	D	Discontinued by firm		2026-08-17

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 · 20 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	70518-2178-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	70518-2178-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	70518-2178-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	70518-2178-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	70518-2178-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	70518-2178-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	70518-2178-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	70518-2178-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	70518-2178-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	70518-2178-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	70518-2178-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	70518-2178-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	70518-2178-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	70518-2178-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	70518-2178-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	70518-2178-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	70518-2178-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	70518-2178-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	70518-2178-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	70518-2178-1	`367a005e9d99…`	`383a685ebd0f…`

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
A210971-001	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2018-10-03
A210971-002	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2018-10-03
A210971-003	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2018-10-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210971-001	AB
A210971-002	AB
A210971-003	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	A210971-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2018-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210971-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2018-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210971-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2018-10-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210971-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2018-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210971-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2018-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210971-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2018-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210971-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2018-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210971-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2018-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210971-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2018-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210971-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2018-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210971-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2018-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210971-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2018-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210971-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2018-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210971-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2018-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210971-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2018-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210971-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2018-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210971-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2018-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210971-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2018-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210971-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2018-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210971-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2018-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210971-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2018-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210971-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2018-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210971-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2018-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210971-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2018-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210971-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2018-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210971-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2018-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210971-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2018-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210971-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2018-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210971-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2018-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210971-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2018-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210971-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2018-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210971-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2018-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210971-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2018-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210971-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2018-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210971-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2018-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210971-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2018-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210971-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2018-10-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210971-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2018-10-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210971-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2018-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210971-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2018-10-03	`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	A210971-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210971-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210971-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210971-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210971-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210971-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210971-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210971-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210971-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210971-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210971-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210971-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210971-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210971-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210971-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210971-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210971-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210971-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210971-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210971-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210971-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210971-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210971-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210971-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210971-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210971-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210971-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210971-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210971-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210971-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210971-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210971-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210971-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210971-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210971-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210971-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210971-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210971-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210971-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210971-001	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	2 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
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
4eaa58c1-a5c5-49b4-a8ac-89f12eb29222	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	SPL version
70518-2178-0	Prazosin Hydrochloride	30 in 1 BLISTER PACK	CAPSULE	30	13
70518-2178-1	Prazosin Hydrochloride	30 in 1 BLISTER PACK	CAPSULE	30	13
70518-2178-2	Prazosin Hydrochloride	100 in 1 BOX	CAPSULE	100	13
70518-2178-3	Prazosin Hydrochloride	1 in 1 POUCH	CAPSULE	1	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-2178	PRAZOSIN HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]	10	Current NDC, Legacy NDC, 4 package rows	20250308_4eaa58c1-a5c5-49b4-a8ac-89f12eb29222.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	REMEDYREPACK INC.	4eaa58c1-a5c5-49b4-a8ac-89f12eb29222	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210971 application number: ANDA210971 ndc (product): 70518-2178
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	35c7aa71-6171-4ba5-916c-384c28e5f5c1	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210971 application number: ANDA210971
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	59602472-65d1-4ad8-8dad-a96a0f4cae0c	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210971 application number: ANDA210971
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Coupler LLC	5358bc3c-912c-bba4-e063-6394a90a4457	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210971 application number: ANDA210971
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	511b4409-7273-4b74-ae55-47c97f0c3ea4	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210971 application number: ANDA210971
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Coupler LLC	518c9848-bf84-9742-e063-6394a90aea2f	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210971 application number: ANDA210971
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Coupler LLC	5103a3cc-e88f-df52-e063-6294a90aec78	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210971 application number: ANDA210971
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Cardinal Health 107, LLC	6209ae19-7ea0-437d-8e5d-12e37917ed13	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210971 application number: ANDA210971
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	REMEDYREPACK INC.	fd860756-9b2e-4bfd-9063-bc4d26366fe6	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210971 application number: ANDA210971
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Major Pharmaceuticals	4f55f4db-dab3-4e50-9f71-5595fd3ccc12	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210971 application number: ANDA210971
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4870901f-5277-e6c0-e063-6394a90a1d3c	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210971 application number: ANDA210971
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Marlex Pharmaceuticals Inc	1c28c337-6dbb-46bd-aa86-dbcd34e3f6e6	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210971 application number: ANDA210971
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	0e48b26e-afbe-4c61-93f4-f6548d05ea8c	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210971 application number: ANDA210971
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	c4449fa8-a637-4780-8e19-51cb54e1ee68	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210971 application number: ANDA210971
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	A-S Medication Solutions	8a6fd4a0-4edd-41d5-a4dc-ce37bc1a67cc	2023-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210971 application number: ANDA210971
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	bf6dbac4-a3d4-4689-8e74-072362328cd3	2023-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210971 application number: ANDA210971

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
312594	prazosin HCl 2 MG Oral Capsule	PSN	4eaa58c1-a5c5-49b4-a8ac-89f12eb29222	13
312594	prazosin 2 MG Oral Capsule	SCD	4eaa58c1-a5c5-49b4-a8ac-89f12eb29222	13
312594	prazosin (as prazosin HCl) 2 MG Oral Capsule	SY	4eaa58c1-a5c5-49b4-a8ac-89f12eb29222	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2178-0	70518217800	30 CAPSULE in 1 BLISTER PACK (70518-2178-0)	30 capsule	2019-07-01	0000-00-00	No	No	Current
70518-2178-1	70518217801	30 CAPSULE in 1 BLISTER PACK (70518-2178-1)	30 capsule	2020-06-23	0000-00-00	No	No	Current
70518-2178-2	70518217802	100 POUCH in 1 BOX (70518-2178-2) / 1 CAPSULE in 1 POUCH (70518-2178-3)	100 pouch	2023-03-28		No	No	Current
70518-2178-3	70518217803	1 in 1 POUCH						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prazosin Hydrochloride Capsules, USP 1 mg, 2 mg and 5 mg	REMEDYREPACK INC.	2026-07-20	HUMAN PRESCRIPTION DRUG LABEL	14