Phenoxybenzamine hydrochloride

Product NDC: 60219-1502
11-digit product format: 602191502
Labeler code: 60219
Product ID: 60219-1502_f872082d-e917-4945-9cd8-59c082cd32d8
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
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: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Phenoxybenzamine hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENOXYBENZAMINE HYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
X1IEG24OHL	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
861402	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
0be6a394-cd10-42fc-97cf-ad53d81d8d93	Available on FDA.report

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
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60219-1502-1	Phenoxybenzamine hydrochloride	100 in 1 BOTTLE	CAPSULE	100		11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60219-1502	PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]	11	Current NDC, Legacy NDC, 1 package rows	20240117_0be6a394-cd10-42fc-97cf-ad53d81d8d93.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 ndc (product): 60219-1502

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	0be6a394-cd10-42fc-97cf-ad53d81d8d93	11
861402	phenoxybenzamine hydrochloride 10 MG Oral Capsule	SCD	0be6a394-cd10-42fc-97cf-ad53d81d8d93	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60219-1502-1	60219150201	100 CAPSULE in 1 BOTTLE (60219-1502-1)	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	2026-07-03	HUMAN PRESCRIPTION DRUG LABEL	12