Phenoxybenzamine Hydrochloride
Phenoxybenzamine Hydrochloride Capsules, USP 10 mg adrenergic, -receptor-blocking agent Rx only
Approved
Approval ID
2cb5fcd7-c37f-41de-8beb-0c7eded9ed04
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2022
Manufacturers
FDA
Novitium Pharma LLC
DUNS: 080301870
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 Code70954-365
Application NumberANDA215042
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phenoxybenzamine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 18, 2022
FDA Product Classification
INGREDIENTS (18)
PHENOXYBENZAMINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: X1IEG24OHL
Classification: ACTIB
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 10/18/2022
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Phenoxybenzamine Hydrochloride Capsules, USP 10 mg
100 capsules per bottle
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 10/18/2022
STORAGE
Store at 25°C (77°F); excursions permitted to 15°- 30°C (59°- 86°F) [See USP Controlled Room Temperature]. Dispense in a tight container.