Venlafaxine Hydrochloride

Product NDC
52959-890
11-digit product format
529590890
Labeler code
52959
Product ID
52959-890_ad9cf8c5-39b6-451c-9fb1-d0ec1bf08679
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-890-30Venlafaxine Hydrochloride30 in 1 BOTTLETABLET304
52959-890-60Venlafaxine Hydrochloride60 in 1 BOTTLETABLET604
52959-890-90Venlafaxine Hydrochloride90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-890-30EA - Each52959-8902ab85856-4ef8-44e6-b534-d9b619df3f0712012-07-24
52959-890-60EA - Each52959-8905af906d9-fd4d-493f-90cf-97fac3de91db12012-07-24
52959-890-90EA - Each52959-89028b96fe9-7f2e-4eaa-9dca-c2ac0cd3e15d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]4
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVENLAFAXINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VENLAFAXINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2VENLAFAXINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-890VENLAFAXINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]4Legacy NDC, 3 package rows20111205_04c95282-2e10-4ab5-baf2-62d44dd8f22f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313586venlafaxine HCl 75 MG Oral TabletPSN04c95282-2e10-4ab5-baf2-62d44dd8f22f4
313586venlafaxine 75 MG Oral TabletSCD04c95282-2e10-4ab5-baf2-62d44dd8f22f4
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY04c95282-2e10-4ab5-baf2-62d44dd8f22f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-890-305295908903030 in 1 BOTTLEHistorical
52959-890-605295908906060 in 1 BOTTLEHistorical
52959-890-905295908909090 in 1 BOTTLEHistorical