Benzphetamine Hydrochloride
Benzphetamine Hydrochloride Tablets, 25 mg and 50 mg CIII
Approved
Approval ID
5f5b95b3-a18f-4289-b9a6-a3278ef5966d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2016
Manufacturers
FDA
Nivagen Pharmaceuticals, Inc.
DUNS: 052032418
Products 2
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 Code75834-102
Application NumberANDA040747
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benzphetamine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2016
FDA Product Classification
INGREDIENTS (6)
Polyethylene GlycolsInactive
Code: 3WJQ0SDW1A
Classification: IACT
Benzphetamine HydrochlorideActive
Quantity: 50 mg in 1 1
Code: 43DWT87QT7
Classification: ACTIB
Calcium StearateInactive
Code: 776XM7047L
Classification: IACT
Lactose, Unspecified FormInactive
Code: J2B2A4N98G
Classification: IACT
SorbitolInactive
Code: 506T60A25R
Classification: IACT
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
Benzphetamine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75834-100
Application NumberANDA040747
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benzphetamine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2016
FDA Product Classification
INGREDIENTS (6)
Calcium StearateInactive
Code: 776XM7047L
Classification: IACT
Benzphetamine HydrochlorideActive
Quantity: 25 mg in 1 1
Code: 43DWT87QT7
Classification: ACTIB
Lactose, Unspecified FormInactive
Code: J2B2A4N98G
Classification: IACT
SorbitolInactive
Code: 506T60A25R
Classification: IACT
Polyethylene GlycolsInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT