Phenoxybenzamine Hydrochloride

Product NDC: 49884-038
Requested package NDC: 49884-038-01
11-digit product format: 498840038
Labeler code: 49884
Product ID: 49884-038_18957b76-0baa-495e-8917-03b6fc16d065
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenoxybenzamine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Par Pharmaceutical, Inc.
Application: ANDA204522
Marketing category: ANDA
Marketing start: 2017-01-24
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: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	49884-038	49884-038-01	D	Discontinued by firm		2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A204522-001	PHENOXYBENZAMINE HYDROCHLORIDE	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS	2017-01-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204522-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A204522-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS	2017-01-24	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A204522-001	AB	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-038-01	EA - Each	49884-038	01195b4d-8c0a-4098-9a1f-6d465bfe7976	1	2017-05-03

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-038-01	49884003801	100 CAPSULE in 1 BOTTLE (49884-038-01)	100 capsule	2017-01-24	0000-00-00	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	Endo USA, Inc.	2024-11-27	HUMAN PRESCRIPTION DRUG LABEL	13