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Phenoxybenzamine Hydrochloride

Rx Only Prescribing Information Phenoxybenzamine hydrochloride capsules, USP 10 mg  adrenergic, -receptor-blocking agent

Approved
Approval ID

29ddb739-0f8e-4c41-ab4b-a6331ae2d508

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 4, 2023

Manufacturers
FDA

Prasco Laboratories

DUNS: 065969375

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Phenoxybenzamine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code66993-066
Application NumberNDA008708
Product Classification
M
Marketing Category
C73605
G
Generic Name
Phenoxybenzamine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 10, 2018
FDA Product Classification

INGREDIENTS (6)

D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
PHENOXYBENZAMINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: X1IEG24OHL
Classification: ACTIB
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT

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Phenoxybenzamine Hydrochloride - FDA Drug Approval Details