Venlafaxine Hydrochloride
These highlights do not include all the information needed to use Venlafaxine Extended Release Tablets safely and effectively. See full prescribing information for Venlafaxine Extended Release Tablets. Venlafaxine Extended Release Tablets (venlafaxine hydrochloride) Extended Release Tablets for Oral useInitial U.S. Approval: 1993
Approved
Approval ID
6148707f-625f-47be-b4bf-b5966078675d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
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 Code54868-6127
Application NumberNDA022104
Product Classification
M
Marketing Category
C73594
G
Generic Name
venlafaxine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2011
FDA Product Classification
INGREDIENTS (13)
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
venlafaxine hydrochlorideActive
Quantity: 37.5 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIB
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT