Phenoxybenzamine hydrochloride

Product NDC: 69238-1502
Requested package NDC: 69238-1502-1
11-digit product format: 692381502
Labeler code: 69238
Product ID: 69238-1502_2b4f097e-fd61-43cb-b6ed-01fbf2868cf7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenoxybenzamine hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA212568
Marketing category: ANDA
Marketing start: 2020-10-30
Marketing end: 0000-00-00
Substance: PHENOXYBENZAMINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69238-1502	69238-1502-1	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 · 18 matching rows.

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

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB		2020-10-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212568-001	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.

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	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212568-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2020-10-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212568-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212568-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212568-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212568-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212568-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212568-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212568-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212568-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212568-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212568-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212568-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212568-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212568-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212568-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212568-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212568-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212568-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212568-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212568-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212568-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212568-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212568-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212568-001	AB	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212568-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212568-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212568-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212568-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212568-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212568-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212568-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212568-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212568-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212568-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212568-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212568-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212568-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212568-001	AB	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
805d9e5d-594b-7d44-2033-963b5e3698ba	Product name	5	20240723
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69238-1502-1	2022-01-28	C162847	48780-1	d6a99b3a-0070-a426-e053-dadaa90af4c2	Phenoxybenzamine Hydrochloride Capsules, USP (10 mg) Rx only Adrenergic, alpha -receptor-blocking agent

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69238-1502-1	Phenoxybenzamine hydrochloride	100 in 1 BOTTLE	CAPSULE	100		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69238-1502	PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]	5	Legacy NDC, 1 package rows	20201220_1daacf09-355c-4e22-88b0-dcd1e18f13d2.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phenoxybenzamine hydrochloride	PHENOXYBENZAMINE HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	0be6a394-cd10-42fc-97cf-ad53d81d8d93	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212568 application number: ANDA212568

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X1IEG24OHL	PHENOXYBENZAMINE HYDROCHLORIDE	63-92-3	PHENOXYBENZAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861402	phenoxybenzamine HCl 10 MG Oral Capsule	PSN	1daacf09-355c-4e22-88b0-dcd1e18f13d2	5
861402	phenoxybenzamine hydrochloride 10 MG Oral Capsule	SCD	1daacf09-355c-4e22-88b0-dcd1e18f13d2	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69238-1502-1	69238150201	100 CAPSULE in 1 BOTTLE (69238-1502-1)	100 capsule	2020-10-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phenoxybenzamine Hydrochloride Capsules, USP (10 mg) Rx only Adrenergic, alpha -receptor-blocking agent	Amneal Pharmaceuticals NY LLC \| Amneal Pharmaceuticals of New York, LLC	2020-12-07	HUMAN PRESCRIPTION DRUG LABEL	5