FDA.reportPublic FDA data

VENLAFAXINE

Product NDC
61919-495
11-digit product format
619190495
Labeler code
61919
Product ID
61919-495_f2147684-a854-54bb-e053-2995a90a736c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA078627
Marketing category
ANDA
Marketing start
2019-08-12
Marketing end
0000-00-00
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
2024-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-495-302025-01-30C16284748780-12cef2736-9b1c-d83d-e063-dadaa90ab31fVENLAFAXINE
61919-495-902020-01-31C16284748780-19d75b9d0-52a5-f424-e053-dadaa90a57ceVENLAFAXINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-495-30VENLAFAXINE30 in 1 BOTTLETABLET304
61919-495-90VENLAFAXINE90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-495-30EA - Each61919-49563f24fc5-dd1a-4980-bda3-78525da76a5b12019-09-05
61919-495-90EA - Each61919-495f774a0a4-1a12-4c76-b090-25fdab1b9be012016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE TABLET [DIRECTRX]1
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE TABLET [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE TABLET [DIRECTRX]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VENLAFAXINE TABLET [DIRECTRX]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE TABLET [DIRECTRX]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVENLAFAXINE TABLET [DIRECTRX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE TABLET [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VENLAFAXINE TABLET [DIRECTRX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2VENLAFAXINE TABLET [DIRECTRX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVENLAFAXINE TABLET [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-495VENLAFAXINE TABLET [DIRECT_RX]4Legacy NDC, 1 package rows20230113_8ff1a5fc-93f8-5782-e053-2a95a90a1785.zip
61919-495VENLAFAXINE TABLET [DIRECTRX]1Legacy NDC, 1 package rows20151112_7df8bea9-2149-42a8-b50e-c8dda8b3c811.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313586venlafaxine HCl 75 MG Oral TabletPSN8ff1a5fc-93f8-5782-e053-2a95a90a17854
313586venlafaxine 75 MG Oral TabletSCD8ff1a5fc-93f8-5782-e053-2a95a90a17854
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY8ff1a5fc-93f8-5782-e053-2a95a90a17854
313586venlafaxine HCl 75 MG Oral TabletPSN7df8bea9-2149-42a8-b50e-c8dda8b3c8111
313586venlafaxine 75 MG Oral TabletSCD7df8bea9-2149-42a8-b50e-c8dda8b3c8111
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY7df8bea9-2149-42a8-b50e-c8dda8b3c8111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-495-306191904953030 TABLET in 1 BOTTLE (61919-495-30) 30 tablet2019-08-120000-00-00NoNoCurrent
61919-495-906191904959090 in 1 BOTTLEHistorical