PHENOXYBENZAMINE HYDROCHLORIDE

Product NDC: 35573-473
11-digit product format: 355730473
Labeler code: 35573
Product ID: 35573-473_609aa41e-4cb5-4cdf-9137-f429c21b4fab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PHENOXYBENZAMINE HYDROCHLORIDE
Dosage form: CAPSULE
Route: ORAL
Labeler: Burel Pharmaceuticals, LLC
Application: ANDA215600
Marketing category: ANDA
Marketing start: 2023-05-08
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
A215600-001	PHENOXYBENZAMINE HYDROCHLORIDE	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB		2023-05-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215600-001	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	A215600-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-05-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215600-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215600-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215600-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215600-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215600-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-05-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215600-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-05-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215600-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-05-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215600-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-05-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215600-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-05-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215600-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-05-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215600-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-05-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215600-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-05-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215600-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-05-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215600-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-05-08	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215600-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-05-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215600-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-05-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215600-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL		2023-05-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215600-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-05-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215600-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-05-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215600-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-05-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215600-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-05-08	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215600-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-05-08	`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	A215600-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215600-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215600-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215600-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215600-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215600-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215600-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215600-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215600-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215600-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215600-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215600-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215600-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215600-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215600-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215600-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215600-001	AB	1	`1c564ffb4f44…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215600-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215600-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215600-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215600-001	AB	1	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215600-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: PHENOXYBENZAMINE HYDROCHLORIDE
Listing expiration: 2026-12-31

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
609aa41e-4cb5-4cdf-9137-f429c21b4fab	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
35573-473-02	PHENOXYBENZAMINE HYDROCHLORIDE	100 in 1 BOTTLE	CAPSULE	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
35573-473-02	EA - Each	35573-473	238c4aa3-010f-4a38-a1a0-6692f00ca9e6	1	2025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35573-473	PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [BUREL PHARMACEUTICALS, LLC]	1	Current NDC, 1 package rows	20250110_609aa41e-4cb5-4cdf-9137-f429c21b4fab.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PHENOXYBENZAMINE HYDROCHLORIDE	PHENOXYBENZAMINE HYDROCHLORIDE	NorthStar Rx LLC	48a047c0-f409-420b-990a-2cab953a96cd	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215600 application number: ANDA215600
PHENOXYBENZAMINE HYDROCHLORIDE	PHENOXYBENZAMINE HYDROCHLORIDE	Burel Pharmaceuticals, LLC	609aa41e-4cb5-4cdf-9137-f429c21b4fab	2024-08-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215600 application number: ANDA215600 ndc (product): 35573-473
PHENOXYBENZAMINE HYDROCHLORIDE	PHENOXYBENZAMINE HYDROCHLORIDE	Aurobindo Pharma Limited	75f26681-a079-4ff3-9fff-75526041374c	2024-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215600 application number: ANDA215600

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	609aa41e-4cb5-4cdf-9137-f429c21b4fab	1
861402	phenoxybenzamine hydrochloride 10 MG Oral Capsule	SCD	609aa41e-4cb5-4cdf-9137-f429c21b4fab	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
35573-473-02	35573047302	100 CAPSULE in 1 BOTTLE (35573-473-02)	100 capsule	2023-05-08	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phenoxybenzamine Hydrochloride Capsules, USP 10 mg adrenergic, alpha- receptor-blocking agent Rx only	Burel Pharmaceuticals, LLC \| Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2024-08-09	Human Prescription Drug Label	1