Phenoxybenzamine Hydrochloride

Product NDC
49884-038
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.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49884-038DDiscontinued by firm2026-07-31
excluded packagepackage49884-03849884-038-01DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204522-001PHENOXYBENZAMINE HYDROCHLORIDEPHENOXYBENZAMINE HYDROCHLORIDE10MGCAPSULE / ORALABRS2017-01-24

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A204522-001AB

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-038-01EA - Each49884-03801195b4d-8c0a-4098-9a1f-6d465bfe797612017-05-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-038-0149884003801100 CAPSULE in 1 BOTTLE (49884-038-01) 100 capsule2017-01-240000-00-00NoNoCurrent