FDA.reportPublic FDA data

VENLAFAXINE

Product NDC
61919-940
11-digit product format
619190940
Labeler code
61919
Product ID
61919-940_be637ae2-4a14-4afd-ac91-099c39cc0829
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE
Dosage form
TABLET
Route
ORAL
Labeler
DirectRX
Application
ANDA078627
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
38 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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
61919-940-302020-01-31C16284748780-19d75b9d0-ac69-f424-e053-dadaa90a57ceVENLAFAXINE
61919-940-602020-01-31C16284748780-19d75b9d0-ac69-f424-e053-dadaa90a57ceVENLAFAXINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-940-30VENLAFAXINE30 in 1 BOTTLETABLET302
61919-940-60VENLAFAXINE60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-940-30EA - Each61919-940ca27e4ea-afaf-4ca5-980a-9fc9b544741212016-06-14
61919-940-60EA - Each61919-9407cb1853d-84e0-4f10-b7f1-f3a6b4319f4f12016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
61919-940VENLAFAXINE TABLET [DIRECTRX]2Legacy NDC, 2 package rows20151123_5464ff4b-8999-437d-a864-d448dafae9cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionStatus
61919-940-306191909403030 in 1 BOTTLEHistorical
61919-940-606191909406060 in 1 BOTTLEHistorical