FDA.reportPublic FDA data

Venlafaxine

Product NDC
68382-019
11-digit product format
683820019
Labeler code
68382
Product ID
68382-019_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
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
68382-019-01Venlafaxine100 in 1 BOTTLETABLET10019
68382-019-05Venlafaxine500 in 1 BOTTLETABLET50019
68382-019-06Venlafaxine30 in 1 BOTTLETABLET3019
68382-019-10Venlafaxine1000 in 1 BOTTLETABLET100019
68382-019-14Venlafaxine60 in 1 BOTTLETABLET6019
68382-019-16Venlafaxine90 in 1 BOTTLETABLET9019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-019-01EA - Each68382-0198416e6d4-73f0-4278-8fa0-8260d30c10f812012-07-24
68382-019-10EA - Each68382-01927ee08f5-566d-4a97-885d-8970fd95a12512012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-019VENLAFAXINE 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
313584venlafaxine HCl 37.5 MG Oral TabletPSN1471508e-7fe4-43db-94ea-b4df1bcbafa9101
313584venlafaxine 37.5 MG Oral TabletSCD1471508e-7fe4-43db-94ea-b4df1bcbafa9101
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY1471508e-7fe4-43db-94ea-b4df1bcbafa9101
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
313584venlafaxine HCl 37.5 MG Oral TabletPSN7bbdc9c5-a4b9-44d4-babc-46bd8c2e084a8
313584venlafaxine 37.5 MG Oral TabletSCD7bbdc9c5-a4b9-44d4-babc-46bd8c2e084a8
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY7bbdc9c5-a4b9-44d4-babc-46bd8c2e084a8
313584venlafaxine HCl 37.5 MG Oral TabletPSN017a84aa-0e1f-f560-e063-6294a90a90693
313584venlafaxine 37.5 MG Oral TabletSCD017a84aa-0e1f-f560-e063-6294a90a90693
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY017a84aa-0e1f-f560-e063-6294a90a90693
313584venlafaxine HCl 37.5 MG Oral TabletPSNfab65158-b2f7-1db7-e053-6294a90af2311
313584venlafaxine 37.5 MG Oral TabletSCDfab65158-b2f7-1db7-e053-6294a90af2311
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSYfab65158-b2f7-1db7-e053-6294a90af2311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-019-0168382001901100 TABLET in 1 BOTTLE (68382-019-01) 100 tablet2008-06-130000-00-00NoNoCurrent
68382-019-0568382001905500 TABLET in 1 BOTTLE (68382-019-05) 500 tablet2008-06-130000-00-00NoNoCurrent
68382-019-066838200190630 TABLET in 1 BOTTLE (68382-019-06) 30 tablet2008-06-130000-00-00NoNoCurrent
68382-019-10683820019101000 TABLET in 1 BOTTLE (68382-019-10) 1000 tablet2008-06-130000-00-00NoNoCurrent
68382-019-146838200191460 TABLET in 1 BOTTLE (68382-019-14) 60 tablet2008-06-130000-00-00NoNoCurrent
68382-019-166838200191690 TABLET in 1 BOTTLE (68382-019-16) 90 tablet2008-06-130000-00-00NoNoCurrent