venlafaxine
Venlafaxine Tablets, USP Rx only
Approved
Approval ID
20319949-ccf9-477a-a6e3-53502772deb9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 19, 2023
Manufacturers
FDA
Rising Pharma Holdings, Inc.
DUNS: 116880195
Products 5
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 Code57237-175
Application NumberANDA090555
Product Classification
M
Marketing Category
C73584
G
Generic Name
venlafaxine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 21, 2023
FDA Product Classification
INGREDIENTS (8)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
VENLAFAXINE HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
venlafaxine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57237-174
Application NumberANDA090555
Product Classification
M
Marketing Category
C73584
G
Generic Name
venlafaxine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 21, 2023
FDA Product Classification
INGREDIENTS (8)
VENLAFAXINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
venlafaxine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57237-173
Application NumberANDA090555
Product Classification
M
Marketing Category
C73584
G
Generic Name
venlafaxine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 21, 2023
FDA Product Classification
INGREDIENTS (8)
VENLAFAXINE HYDROCHLORIDEActive
Quantity: 37.5 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
venlafaxine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57237-176
Application NumberANDA090555
Product Classification
M
Marketing Category
C73584
G
Generic Name
venlafaxine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 21, 2023
FDA Product Classification
INGREDIENTS (8)
VENLAFAXINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
venlafaxine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57237-172
Application NumberANDA090555
Product Classification
M
Marketing Category
C73584
G
Generic Name
venlafaxine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 21, 2023
FDA Product Classification
INGREDIENTS (8)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
VENLAFAXINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT