FDA.reportPublic FDA data

Venlafaxine

Product NDC
57664-393
11-digit product format
576640393
Labeler code
57664
Product ID
57664-393_4a916be7-abd4-8771-e063-6394a90a86eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA078627
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Venlafaxine
Listing expiration
2027-12-31

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
57664-393-88Venlafaxine100 in 1 BOTTLETABLET10014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-393-88EA - Each57664-393d7a2025f-843b-49ea-a9d4-d8cb1ca1b55e12014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]9
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]9
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVENLAFAXINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VENLAFAXINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VENLAFAXINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2VENLAFAXINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVENLAFAXINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]9
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]7
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]7
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VENLAFAXINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVENLAFAXINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VENLAFAXINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2VENLAFAXINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVENLAFAXINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]7
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE TABLET [DIRECTRX]2
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE TABLET [DIRECTRX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE TABLET [DIRECTRX]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VENLAFAXINE TABLET [DIRECTRX]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE TABLET [DIRECTRX]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVENLAFAXINE TABLET [DIRECTRX]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE TABLET [DIRECTRX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VENLAFAXINE TABLET [DIRECTRX]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2VENLAFAXINE TABLET [DIRECTRX]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVENLAFAXINE TABLET [DIRECTRX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-393VENLAFAXINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]13Current NDC, Legacy NDC, 1 package rows20231031_55889b3d-74c9-4638-9a14-6a4ca3a99f7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313584venlafaxine HCl 37.5 MG Oral TabletPSNfe2e1d64-784e-464f-9d92-1b537d0dddc115
313586venlafaxine HCl 75 MG Oral TabletPSNfe2e1d64-784e-464f-9d92-1b537d0dddc115
313584venlafaxine 37.5 MG Oral TabletSCDfe2e1d64-784e-464f-9d92-1b537d0dddc115
313586venlafaxine 75 MG Oral TabletSCDfe2e1d64-784e-464f-9d92-1b537d0dddc115
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSYfe2e1d64-784e-464f-9d92-1b537d0dddc115
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSYfe2e1d64-784e-464f-9d92-1b537d0dddc115
313580venlafaxine HCl 100 MG Oral TabletPSN55889b3d-74c9-4638-9a14-6a4ca3a99f7f14
313582venlafaxine HCl 25 MG Oral TabletPSN55889b3d-74c9-4638-9a14-6a4ca3a99f7f14
313584venlafaxine HCl 37.5 MG Oral TabletPSN55889b3d-74c9-4638-9a14-6a4ca3a99f7f14
314277venlafaxine HCl 50 MG Oral TabletPSN55889b3d-74c9-4638-9a14-6a4ca3a99f7f14
313586venlafaxine HCl 75 MG Oral TabletPSN55889b3d-74c9-4638-9a14-6a4ca3a99f7f14
313580venlafaxine 100 MG Oral TabletSCD55889b3d-74c9-4638-9a14-6a4ca3a99f7f14
313582venlafaxine 25 MG Oral TabletSCD55889b3d-74c9-4638-9a14-6a4ca3a99f7f14
313584venlafaxine 37.5 MG Oral TabletSCD55889b3d-74c9-4638-9a14-6a4ca3a99f7f14
314277venlafaxine 50 MG Oral TabletSCD55889b3d-74c9-4638-9a14-6a4ca3a99f7f14
313586venlafaxine 75 MG Oral TabletSCD55889b3d-74c9-4638-9a14-6a4ca3a99f7f14
313580venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral TabletSY55889b3d-74c9-4638-9a14-6a4ca3a99f7f14
313582venlafaxine 25 MG (as venlafaxine hydrochloride 28.3 MG) Oral TabletSY55889b3d-74c9-4638-9a14-6a4ca3a99f7f14
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY55889b3d-74c9-4638-9a14-6a4ca3a99f7f14
314277venlafaxine 50 MG (as venlafaxine hydrochloride 56.6 MG) Oral TabletSY55889b3d-74c9-4638-9a14-6a4ca3a99f7f14
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY55889b3d-74c9-4638-9a14-6a4ca3a99f7f14
313580venlafaxine HCl 100 MG Oral TabletPSN53b73f2a-d839-41b5-bc9c-aeb3e9dba3049
313584venlafaxine HCl 37.5 MG Oral TabletPSN53b73f2a-d839-41b5-bc9c-aeb3e9dba3049
313586venlafaxine HCl 75 MG Oral TabletPSN53b73f2a-d839-41b5-bc9c-aeb3e9dba3049
313580venlafaxine 100 MG Oral TabletSCD53b73f2a-d839-41b5-bc9c-aeb3e9dba3049
313584venlafaxine 37.5 MG Oral TabletSCD53b73f2a-d839-41b5-bc9c-aeb3e9dba3049
313586venlafaxine 75 MG Oral TabletSCD53b73f2a-d839-41b5-bc9c-aeb3e9dba3049
313580venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral TabletSY53b73f2a-d839-41b5-bc9c-aeb3e9dba3049
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY53b73f2a-d839-41b5-bc9c-aeb3e9dba3049
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY53b73f2a-d839-41b5-bc9c-aeb3e9dba3049
313580venlafaxine HCl 100 MG Oral TabletPSNc2a3283f-ba30-f506-e053-2995a90a93785
313582venlafaxine HCl 25 MG Oral TabletPSNc2a3283f-ba30-f506-e053-2995a90a93785
313584venlafaxine HCl 37.5 MG Oral TabletPSNc2a3283f-ba30-f506-e053-2995a90a93785
314277venlafaxine HCl 50 MG Oral TabletPSNc2a3283f-ba30-f506-e053-2995a90a93785
313586venlafaxine HCl 75 MG Oral TabletPSNc2a3283f-ba30-f506-e053-2995a90a93785
313580venlafaxine 100 MG Oral TabletSCDc2a3283f-ba30-f506-e053-2995a90a93785
313582venlafaxine 25 MG Oral TabletSCDc2a3283f-ba30-f506-e053-2995a90a93785
313584venlafaxine 37.5 MG Oral TabletSCDc2a3283f-ba30-f506-e053-2995a90a93785
314277venlafaxine 50 MG Oral TabletSCDc2a3283f-ba30-f506-e053-2995a90a93785
313586venlafaxine 75 MG Oral TabletSCDc2a3283f-ba30-f506-e053-2995a90a93785
313580venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral TabletSYc2a3283f-ba30-f506-e053-2995a90a93785
313582venlafaxine 25 MG (as venlafaxine hydrochloride 28.3 MG) Oral TabletSYc2a3283f-ba30-f506-e053-2995a90a93785
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSYc2a3283f-ba30-f506-e053-2995a90a93785
314277venlafaxine 50 MG (as venlafaxine hydrochloride 56.6 MG) Oral TabletSYc2a3283f-ba30-f506-e053-2995a90a93785
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSYc2a3283f-ba30-f506-e053-2995a90a93785
313584venlafaxine HCl 37.5 MG Oral TabletPSN34734ecc-9b96-4a75-9418-1cc0401c24293
314277venlafaxine HCl 50 MG Oral TabletPSN34734ecc-9b96-4a75-9418-1cc0401c24293
313584venlafaxine 37.5 MG Oral TabletSCD34734ecc-9b96-4a75-9418-1cc0401c24293
314277venlafaxine 50 MG Oral TabletSCD34734ecc-9b96-4a75-9418-1cc0401c24293
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY34734ecc-9b96-4a75-9418-1cc0401c24293
314277venlafaxine 50 MG (as venlafaxine hydrochloride 56.6 MG) Oral TabletSY34734ecc-9b96-4a75-9418-1cc0401c24293
313584venlafaxine HCl 37.5 MG Oral TabletPSN5464ff4b-8999-437d-a864-d448dafae9cd2
313584venlafaxine 37.5 MG Oral TabletSCD5464ff4b-8999-437d-a864-d448dafae9cd2
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY5464ff4b-8999-437d-a864-d448dafae9cd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57664-393-8857664039388100 TABLET in 1 BOTTLE (57664-393-88) 100 tablet2008-06-130000-00-00NoNoCurrent