Venlafaxine
Venlafaxine Tablets, USP
Approved
Approval ID
1b607fc8-294a-4892-925a-5fb9e0e81ed5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 30, 2023
Manufacturers
FDA
Northstar Rx LLC
DUNS: 830546433
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Venlafaxine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-659
Application NumberANDA078627
Product Classification
M
Marketing Category
C73584
G
Generic Name
Venlafaxine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (9)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
VENLAFAXINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM
Venlafaxine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-658
Application NumberANDA078627
Product Classification
M
Marketing Category
C73584
G
Generic Name
Venlafaxine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (9)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
VENLAFAXINE HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Venlafaxine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-656
Application NumberANDA078627
Product Classification
M
Marketing Category
C73584
G
Generic Name
Venlafaxine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (9)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
VENLAFAXINE HYDROCHLORIDEActive
Quantity: 37.5 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM
Venlafaxine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-655
Application NumberANDA078627
Product Classification
M
Marketing Category
C73584
G
Generic Name
Venlafaxine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (9)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
VENLAFAXINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM
Venlafaxine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-657
Application NumberANDA078627
Product Classification
M
Marketing Category
C73584
G
Generic Name
Venlafaxine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (9)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
VENLAFAXINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM