Phenoxybenzamine hydrochloride
Phenoxybenzamine Hydrochloride Capsules, USP (10 mg) Rx only Adrenergic, -receptor-blocking agent
Approved
Approval ID
1daacf09-355c-4e22-88b0-dcd1e18f13d2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 7, 2020
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
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 Code69238-1502
Application NumberANDA212568
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phenoxybenzamine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2020
FDA Product Classification
INGREDIENTS (16)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PHENOXYBENZAMINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: X1IEG24OHL
Classification: ACTIB
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 12/7/2020
PRINCIPAL DISPLAY PANEL
NDC 69238-1502-1
Phenoxybenzamine Hydrochloride Capsules USP, 10 mg
100 Capsules
Rx only
Amneal Pharmaceuticals LLC
