Venlafaxine Hydrochloride
VENLAFAXINE HYDROCHLORIDE TABLETS
Approved
Approval ID
f1f123a3-d52b-4d27-aba2-db315565be80
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 9, 2014
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Venlafaxine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-690
Application NumberANDA090027
Product Classification
M
Marketing Category
C73584
G
Generic Name
Venlafaxine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 9, 2014
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
VENLAFAXINE HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Venlafaxine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-689
Application NumberANDA090027
Product Classification
M
Marketing Category
C73584
G
Generic Name
Venlafaxine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 9, 2014
FDA Product Classification
INGREDIENTS (7)
VENLAFAXINE HYDROCHLORIDEActive
Quantity: 37.5 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT