FDA.reportPublic FDA data

Venlafaxine

Product NDC
65862-405
11-digit product format
658620405
Labeler code
65862
Product ID
65862-405_426d12db-50e2-4915-999f-84645fb387d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA090555
Marketing category
ANDA
Marketing start
2010-04-07
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
37.5 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Venlafaxine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313580, 313582, 313584, 313586, 314277

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
17db3736-056c-48b9-b0f4-00fccabb14e6Product name520251118
7be8b949-f2c0-bdd8-e89d-8af92c1b2eadProduct name920250224
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-405-01Venlafaxine100 in 1 BOTTLETABLET10019
65862-405-10Venlafaxine10 in 1 BLISTER PACKTABLET1019
65862-405-10Venlafaxine10 in 1 CARTONTABLET1019
65862-405-30Venlafaxine30 in 1 BOTTLETABLET3019
65862-405-60Venlafaxine60 in 1 BOTTLETABLET6019
65862-405-66Venlafaxine6000 in 1 BOTTLETABLET600019
65862-405-90Venlafaxine90 in 1 BOTTLETABLET9019
65862-405-99Venlafaxine1000 in 1 BOTTLETABLET100019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-405-01EA - Each65862-40504bd01e9-5b24-4bb0-8f91-71dabed3c96a12012-07-24
65862-405-60EA - Each65862-405215e4e17-5cb5-4967-bb2b-94c3d5c6137c12012-07-24
65862-405-90EA - Each65862-4056d8de601-2ccb-4f23-b66d-6d498268a66012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]10
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]10
POVIDONE K30INACTIVE INGREDIENTU725QWY32XVENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-405VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]19Current NDC, Legacy NDC, 8 package rows20230823_b23637e5-d37f-41b5-ba76-fc053e903bc2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313580venlafaxine HCl 100 MG Oral TabletPSNb23637e5-d37f-41b5-ba76-fc053e903bc219
313582venlafaxine HCl 25 MG Oral TabletPSNb23637e5-d37f-41b5-ba76-fc053e903bc219
313584venlafaxine HCl 37.5 MG Oral TabletPSNb23637e5-d37f-41b5-ba76-fc053e903bc219
314277venlafaxine HCl 50 MG Oral TabletPSNb23637e5-d37f-41b5-ba76-fc053e903bc219
313586venlafaxine HCl 75 MG Oral TabletPSNb23637e5-d37f-41b5-ba76-fc053e903bc219
313580venlafaxine 100 MG Oral TabletSCDb23637e5-d37f-41b5-ba76-fc053e903bc219
313582venlafaxine 25 MG Oral TabletSCDb23637e5-d37f-41b5-ba76-fc053e903bc219
313584venlafaxine 37.5 MG Oral TabletSCDb23637e5-d37f-41b5-ba76-fc053e903bc219
314277venlafaxine 50 MG Oral TabletSCDb23637e5-d37f-41b5-ba76-fc053e903bc219
313586venlafaxine 75 MG Oral TabletSCDb23637e5-d37f-41b5-ba76-fc053e903bc219
313580venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral TabletSYb23637e5-d37f-41b5-ba76-fc053e903bc219
313582venlafaxine 25 MG (as venlafaxine hydrochloride 28.3 MG) Oral TabletSYb23637e5-d37f-41b5-ba76-fc053e903bc219
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSYb23637e5-d37f-41b5-ba76-fc053e903bc219
314277venlafaxine 50 MG (as venlafaxine hydrochloride 56.6 MG) Oral TabletSYb23637e5-d37f-41b5-ba76-fc053e903bc219
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSYb23637e5-d37f-41b5-ba76-fc053e903bc219

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-405-0165862040501100 TABLET in 1 BOTTLE (65862-405-01) 100 tablet2010-04-070000-00-00NoNoCurrent
65862-405-106586204051010 BLISTER PACK in 1 CARTON (65862-405-10) / 10 TABLET in 1 BLISTER PACK10 blister pack2010-04-070000-00-00NoNoCurrent
65862-405-306586204053030 TABLET in 1 BOTTLE (65862-405-30) 30 tablet2010-04-070000-00-00NoNoCurrent
65862-405-606586204056060 TABLET in 1 BOTTLE (65862-405-60) 60 tablet2010-04-070000-00-00NoNoCurrent
65862-405-66658620405666000 TABLET in 1 BOTTLE (65862-405-66) 6000 tablet2010-04-070000-00-00NoNoCurrent
65862-405-906586204059090 TABLET in 1 BOTTLE (65862-405-90) 90 tablet2010-04-070000-00-00NoNoCurrent
65862-405-99658620405991000 TABLET in 1 BOTTLE (65862-405-99) 1000 tablet2010-04-070000-00-00NoNoCurrent