prazosin hydrochloride

Product NDC: 70518-3669
11-digit product format: 705183669
Labeler code: 70518
Product ID: 70518-3669_4f7ecb0e-2d84-8a8d-e063-6394a90a6671
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: prazosin hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA215697
Marketing category: ANDA
Marketing start: 2023-03-03
Substance: PRAZOSIN HYDROCHLORIDE
Active strength: 1 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	70518-3669	70518-3669-0	D	Discontinued by firm	2026-08-17
excluded package	package	70518-3669	70518-3669-1	D	Discontinued by firm	2026-08-17
excluded package	package	70518-3669	70518-3669-2	D	Discontinued by firm	2026-08-17
excluded package	package	70518-3669	70518-3669-3	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 · 12 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	70518-3669-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	70518-3669-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	70518-3669-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	70518-3669-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	70518-3669-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	70518-3669-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	70518-3669-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	70518-3669-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	70518-3669-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	70518-3669-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	70518-3669-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	70518-3669-0	`ad56d346431e…`	`cc804d4bbf1e…`

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
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 · 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
2026-08-18 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`1e350fbaab3a…`

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
2026-08-18 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215697-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215697-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215697-001	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	1 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
312593	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
95aa9ffb-66bb-4049-a241-0e1166b4c264	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
70518-3669-0	prazosin hydrochloride	60 in 1 BOTTLE, PLASTIC	CAPSULE	60	13
70518-3669-1	prazosin hydrochloride	30 in 1 BLISTER PACK	CAPSULE	30	13
70518-3669-2	prazosin hydrochloride	60 in 1 BOTTLE, PLASTIC	CAPSULE	60	13
70518-3669-3	prazosin hydrochloride	30 in 1 BLISTER PACK	CAPSULE	30	13
70518-3669-4	prazosin hydrochloride	30 in 1 BOTTLE, PLASTIC	CAPSULE	30	13
70518-3669-5	prazosin hydrochloride	100 in 1 BOX	CAPSULE	100	13
70518-3669-6	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
70518-3669	PRAZOSIN HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]	7	Current NDC, 7 package rows	20250210_95aa9ffb-66bb-4049-a241-0e1166b4c264.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 · 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.	95aa9ffb-66bb-4049-a241-0e1166b4c264	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697 ndc (product): 70518-3669
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
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	REMEDYREPACK INC.	e4852fc2-b763-40e2-b8bb-a3f6da5c72fe	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	e5bd5728-ea7c-4f16-832b-8d58fe14b994	2025-09-10	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312593	prazosin HCl 1 MG Oral Capsule	PSN	95aa9ffb-66bb-4049-a241-0e1166b4c264	13
312593	prazosin 1 MG Oral Capsule	SCD	95aa9ffb-66bb-4049-a241-0e1166b4c264	13
312593	prazosin (as prazosin HCl) 1 MG Oral Capsule	SY	95aa9ffb-66bb-4049-a241-0e1166b4c264	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-3669-0	70518366900	60 in 1 BOTTLE, PLASTIC					Historical
70518-3669-1	70518366901	30 in 1 BLISTER PACK					Historical
70518-3669-2	70518366902	60 in 1 BOTTLE, PLASTIC					Historical
70518-3669-3	70518366903	30 in 1 BLISTER PACK					Historical
70518-3669-4	70518366904	30 CAPSULE in 1 BOTTLE, PLASTIC (70518-3669-4)	30 capsule	2025-08-27	No	No	Current
70518-3669-5	70518366905	100 POUCH in 1 BOX (70518-3669-5) / 1 CAPSULE in 1 POUCH (70518-3669-6)	100 pouch	2026-02-10	No	No	Current
70518-3669-6	70518366906	1 in 1 POUCH					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prazosin Hydrochloride Capsules, USP	REMEDYREPACK INC.	2026-08-14	HUMAN PRESCRIPTION DRUG LABEL	14