Benzphetamine Hydrochloride
Rx Only
Approved
Approval ID
e95dfb31-8365-498d-91ea-79738033f905
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2017
Manufacturers
FDA
Apotheca Inc.
DUNS: 051457844
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 Code12634-118
Application NumberANDA040747
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benzphetamine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2017
FDA Product Classification
INGREDIENTS (6)
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
BENZPHETAMINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 43DWT87QT7
Classification: ACTIB