Benzphetamine Hydrochloride
Rx Only
Approved
Approval ID
5ca0eee3-8f84-4ee2-b339-c9cdbf6ffd52
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2016
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Benzphetamine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53217-175
Application NumberANDA040747
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benzphetamine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2016
FDA Product Classification
INGREDIENTS (6)
BENZPHETAMINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 43DWT87QT7
Classification: ACTIB
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT