Dibenzyline
Rx Only Prescribing Information Dibenzyline (phenoxybenzamine hydrochloride capsules, USP) 10 mg adrenergic, -receptor-blocking agent
Approved
Approval ID
8852dd44-098c-4d99-88e0-a092a8e08e11
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 3, 2023
Manufacturers
FDA
Concordia Pharmaceuticals Inc.
DUNS: 815240092
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 Code59212-001
Application NumberNDA008708
Product Classification
M
Marketing Category
C73594
G
Generic Name
Phenoxybenzamine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 14, 2020
FDA Product Classification
INGREDIENTS (6)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PHENOXYBENZAMINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: X1IEG24OHL
Classification: ACTIB
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT