Prazosin Hydrochloride

Product NDC: 43353-035
11-digit product format: 433530035
Labeler code: 43353
Product ID: 43353-035_722b7796-becb-4bd0-ad66-ef8a4d7ff7b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prazosin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, Inc.
Application: ANDA071995
Marketing category: ANDA
Marketing start: 2009-12-21
Marketing end: 0000-00-00
Substance: PRAZOSIN HYDROCHLORIDE
Active strength: 2 mg/1
Pharmacologic classes: alpha-Adrenergic Blocker [EPC],Adrenergic alpha-Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
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	43353-035		I	Inactivated by FDA		2026-08-17
excluded package	package	43353-035	43353-035-60	I	Inactivated by FDA		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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-035-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-035-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-035-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-035-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-035-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-035-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-035-60	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-035-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-035-60	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-035-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-035-60	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-035-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43353-035-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43353-035-60	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43353-035-60	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43353-035-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43353-035-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43353-035-60	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	43353-035-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	43353-035-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	43353-035-60	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5a3de99-75de-4527-38ae-07b1328b93cb	Product name	5	20250331

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43353-035-60	2020-01-31	C162847	48780-1	9d75b9d0-758e-f424-e053-dadaa90a57ce	PRAZOSIN HYDROCHLORIDE CAPSULES USP 4067 4068 4069 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43353-035-60	Prazosin Hydrochloride	90 in 1 BOTTLE, PLASTIC	CAPSULE	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-035-60	EA - Each	43353-035	b8002f9b-c529-4867-aa63-0fee122e1bce	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PRAZOSIN HYDROCHLORIDE	ACTIVE INGREDIENT	X0Z7454B90	PRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
PRAZOSIN	ACTIVE MOIETY	XM03YJ541D	PRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	PRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-035	PRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1	Legacy NDC, 1 package rows	20120816_021370d8-a61c-4510-b717-40dadcf9a4dc.zip

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	021370d8-a61c-4510-b717-40dadcf9a4dc	1
312594	prazosin 2 MG Oral Capsule	SCD	021370d8-a61c-4510-b717-40dadcf9a4dc	1
312594	prazosin (as prazosin HCl) 2 MG Oral Capsule	SY	021370d8-a61c-4510-b717-40dadcf9a4dc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-035-60	43353003560	90 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRAZOSIN HYDROCHLORIDE CAPSULES USP 4067 4068 4069 Rx only	Aphena Pharma Solutions - Tennessee, Inc.	2012-07-16	HUMAN PRESCRIPTION DRUG LABEL	1