FDA.reportPublic FDA data

Venlafaxine

Product NDC
68382-101
11-digit product format
683820101
Labeler code
68382
Product ID
68382-101_ea404f6c-7e07-4779-a52c-8cffb92718ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA077653
Marketing category
ANDA
Marketing start
2008-06-13
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 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
68382-101-01Venlafaxine100 in 1 BOTTLETABLET10019
68382-101-05Venlafaxine500 in 1 BOTTLETABLET50019
68382-101-06Venlafaxine30 in 1 BOTTLETABLET3019
68382-101-10Venlafaxine1000 in 1 BOTTLETABLET100019
68382-101-14Venlafaxine60 in 1 BOTTLETABLET6019
68382-101-16Venlafaxine90 in 1 BOTTLETABLET9019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-101-01EA - Each68382-10101f7e707-33f4-467a-94f4-8befbc28fd4912012-07-24
68382-101-10EA - Each68382-101f702b84e-5d32-4013-a636-49d8c7e8029a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]8
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVENLAFAXINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VENLAFAXINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2VENLAFAXINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]8
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2VENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-101VENLAFAXINE TABLET [ZYDUS PHARMACEUTICALS USA INC.]19Current NDC, Legacy NDC, 6 package rows20230829_72efad5f-0909-46a5-aa13-ac24fe015fe6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313580venlafaxine HCl 100 MG Oral TabletPSN72efad5f-0909-46a5-aa13-ac24fe015fe619
313582venlafaxine HCl 25 MG Oral TabletPSN72efad5f-0909-46a5-aa13-ac24fe015fe619
313584venlafaxine HCl 37.5 MG Oral TabletPSN72efad5f-0909-46a5-aa13-ac24fe015fe619
314277venlafaxine HCl 50 MG Oral TabletPSN72efad5f-0909-46a5-aa13-ac24fe015fe619
313586venlafaxine HCl 75 MG Oral TabletPSN72efad5f-0909-46a5-aa13-ac24fe015fe619
313580venlafaxine 100 MG Oral TabletSCD72efad5f-0909-46a5-aa13-ac24fe015fe619
313582venlafaxine 25 MG Oral TabletSCD72efad5f-0909-46a5-aa13-ac24fe015fe619
313584venlafaxine 37.5 MG Oral TabletSCD72efad5f-0909-46a5-aa13-ac24fe015fe619
314277venlafaxine 50 MG Oral TabletSCD72efad5f-0909-46a5-aa13-ac24fe015fe619
313586venlafaxine 75 MG Oral TabletSCD72efad5f-0909-46a5-aa13-ac24fe015fe619
313580venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral TabletSY72efad5f-0909-46a5-aa13-ac24fe015fe619
313582venlafaxine 25 MG (as venlafaxine hydrochloride 28.3 MG) Oral TabletSY72efad5f-0909-46a5-aa13-ac24fe015fe619
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY72efad5f-0909-46a5-aa13-ac24fe015fe619
314277venlafaxine 50 MG (as venlafaxine hydrochloride 56.6 MG) Oral TabletSY72efad5f-0909-46a5-aa13-ac24fe015fe619
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY72efad5f-0909-46a5-aa13-ac24fe015fe619
313580venlafaxine HCl 100 MG Oral TabletPSNa4e1d3bc-4e97-4ff0-9e30-22a699c960721
313580venlafaxine HCl 100 MG Oral TabletPSNd4638a83-2720-430c-b529-c852aa2f73661
313582venlafaxine HCl 25 MG Oral TabletPSNa4e1d3bc-4e97-4ff0-9e30-22a699c960721
313586venlafaxine HCl 75 MG Oral TabletPSNa4e1d3bc-4e97-4ff0-9e30-22a699c960721
313580venlafaxine 100 MG Oral TabletSCDa4e1d3bc-4e97-4ff0-9e30-22a699c960721
313580venlafaxine 100 MG Oral TabletSCDd4638a83-2720-430c-b529-c852aa2f73661
313582venlafaxine 25 MG Oral TabletSCDa4e1d3bc-4e97-4ff0-9e30-22a699c960721
313586venlafaxine 75 MG Oral TabletSCDa4e1d3bc-4e97-4ff0-9e30-22a699c960721
313580venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral TabletSYa4e1d3bc-4e97-4ff0-9e30-22a699c960721
313580venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral TabletSYd4638a83-2720-430c-b529-c852aa2f73661
313582venlafaxine 25 MG (as venlafaxine hydrochloride 28.3 MG) Oral TabletSYa4e1d3bc-4e97-4ff0-9e30-22a699c960721
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSYa4e1d3bc-4e97-4ff0-9e30-22a699c960721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-101-0168382010101100 TABLET in 1 BOTTLE (68382-101-01) 100 tablet2008-06-130000-00-00NoNoCurrent
68382-101-0568382010105500 TABLET in 1 BOTTLE (68382-101-05) 500 tablet2008-06-130000-00-00NoNoCurrent
68382-101-066838201010630 TABLET in 1 BOTTLE (68382-101-06) 30 tablet2008-06-130000-00-00NoNoCurrent
68382-101-10683820101101000 TABLET in 1 BOTTLE (68382-101-10) 1000 tablet2008-06-130000-00-00NoNoCurrent
68382-101-146838201011460 TABLET in 1 BOTTLE (68382-101-14) 60 tablet2008-06-130000-00-00NoNoCurrent
68382-101-166838201011690 TABLET in 1 BOTTLE (68382-101-16) 90 tablet2008-06-130000-00-00NoNoCurrent