FDA.reportPublic FDA data

Venlafaxine

Product NDC
68382-021
11-digit product format
683820021
Labeler code
68382
Product ID
68382-021_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
75 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 HYDROCHLORIDE75 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
68382-021-01Venlafaxine100 in 1 BOTTLETABLET10019
68382-021-05Venlafaxine500 in 1 BOTTLETABLET50019
68382-021-06Venlafaxine30 in 1 BOTTLETABLET3019
68382-021-10Venlafaxine1000 in 1 BOTTLETABLET100019
68382-021-14Venlafaxine60 in 1 BOTTLETABLET6019
68382-021-16Venlafaxine90 in 1 BOTTLETABLET9019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-021-01EA - Each68382-0213159432e-1fa8-498f-8aa5-7f2a56476f9312012-07-24
68382-021-10EA - Each68382-021bf6c778d-fc2e-44e1-b187-26923965a84c12012-07-24

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 [H.J. HARKINS COMPANY, INC.]4
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVENLAFAXINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VENLAFAXINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2VENLAFAXINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]4
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVENLAFAXINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VENLAFAXINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2VENLAFAXINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE TABLET [PROFICIENT RX LP]1
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE TABLET [PROFICIENT RX LP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE TABLET [PROFICIENT RX LP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVENLAFAXINE TABLET [PROFICIENT RX LP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VENLAFAXINE TABLET [PROFICIENT RX LP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2VENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2VENLAFAXINE TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-021VENLAFAXINE 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
313586venlafaxine HCl 75 MG Oral TabletPSN185d90ab-1ba4-dd59-0565-e35f0fd39a2d12
313586venlafaxine 75 MG Oral TabletSCD185d90ab-1ba4-dd59-0565-e35f0fd39a2d12
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY185d90ab-1ba4-dd59-0565-e35f0fd39a2d12
313586venlafaxine HCl 75 MG Oral TabletPSNd3475ce0-1368-4961-a9b9-44c5c33cdc588
313586venlafaxine 75 MG Oral TabletSCDd3475ce0-1368-4961-a9b9-44c5c33cdc588
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSYd3475ce0-1368-4961-a9b9-44c5c33cdc588
313586venlafaxine HCl 75 MG Oral TabletPSN04c95282-2e10-4ab5-baf2-62d44dd8f22f4
313586venlafaxine 75 MG Oral TabletSCD04c95282-2e10-4ab5-baf2-62d44dd8f22f4
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY04c95282-2e10-4ab5-baf2-62d44dd8f22f4
313586venlafaxine HCl 75 MG Oral TabletPSNfa1db21b-98b8-3bde-e053-6394a90aa6383
313586venlafaxine HCl 75 MG Oral TabletPSNb5fc0187-590c-4bb9-a910-821eb0dc1fc83
313586venlafaxine 75 MG Oral TabletSCDfa1db21b-98b8-3bde-e053-6394a90aa6383
313586venlafaxine 75 MG Oral TabletSCDb5fc0187-590c-4bb9-a910-821eb0dc1fc83
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSYfa1db21b-98b8-3bde-e053-6394a90aa6383
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSYb5fc0187-590c-4bb9-a910-821eb0dc1fc83
313586venlafaxine HCl 75 MG Oral TabletPSNfe7de51e-8a81-fe68-e053-6294a90a73392
313586venlafaxine 75 MG Oral TabletSCDfe7de51e-8a81-fe68-e053-6294a90a73392
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSYfe7de51e-8a81-fe68-e053-6294a90a73392
313580venlafaxine HCl 100 MG Oral TabletPSNa4e1d3bc-4e97-4ff0-9e30-22a699c960721
313582venlafaxine HCl 25 MG Oral TabletPSNa4e1d3bc-4e97-4ff0-9e30-22a699c960721
313586venlafaxine HCl 75 MG Oral TabletPSN59b3e091-0461-1fd1-e053-2991aa0a5ecc1
313586venlafaxine HCl 75 MG Oral TabletPSNa4e1d3bc-4e97-4ff0-9e30-22a699c960721
313580venlafaxine 100 MG Oral TabletSCDa4e1d3bc-4e97-4ff0-9e30-22a699c960721
313582venlafaxine 25 MG Oral TabletSCDa4e1d3bc-4e97-4ff0-9e30-22a699c960721
313586venlafaxine 75 MG Oral TabletSCD59b3e091-0461-1fd1-e053-2991aa0a5ecc1
313586venlafaxine 75 MG Oral TabletSCDa4e1d3bc-4e97-4ff0-9e30-22a699c960721
313580venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral TabletSYa4e1d3bc-4e97-4ff0-9e30-22a699c960721
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 TabletSY59b3e091-0461-1fd1-e053-2991aa0a5ecc1
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
68382-021-0168382002101100 TABLET in 1 BOTTLE (68382-021-01) 100 tablet2008-06-130000-00-00NoNoCurrent
68382-021-0568382002105500 TABLET in 1 BOTTLE (68382-021-05) 500 tablet2008-06-130000-00-00NoNoCurrent
68382-021-066838200210630 TABLET in 1 BOTTLE (68382-021-06) 30 tablet2008-06-130000-00-00NoNoCurrent
68382-021-10683820021101000 TABLET in 1 BOTTLE (68382-021-10) 1000 tablet2008-06-130000-00-00NoNoCurrent
68382-021-146838200211460 TABLET in 1 BOTTLE (68382-021-14) 60 tablet2008-06-130000-00-00NoNoCurrent
68382-021-166838200211690 TABLET in 1 BOTTLE (68382-021-16) 90 tablet2008-06-130000-00-00NoNoCurrent