FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
42254-144
11-digit product format
422540144
Labeler code
42254
Product ID
42254-144_a4e1d3bc-4e97-4ff0-9e30-22a699c96072
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA077653
Marketing category
ANDA
Marketing start
2008-06-13
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
75 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
42254-144-302019-09-24C16284748780-19350213a-3ce3-c013-e053-90daa90a1393Venlafaxine Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-144-30Venlafaxine Hydrochloride30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-144-30EA - Each42254-144992b31c7-2d28-4ae2-a319-8653357769f012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2VENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-144VENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20120411_a4e1d3bc-4e97-4ff0-9e30-22a699c96072.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 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 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 TabletSYa4e1d3bc-4e97-4ff0-9e30-22a699c960721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-144-304225401443030 in 1 BOTTLEHistorical