FDA.reportPublic FDA data

VENLAFAXINE

Product NDC
61919-535
11-digit product format
619190535
Labeler code
61919
Product ID
61919-535_9cad8725-3ed8-9045-e053-2a95a90a5b88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA078554
Marketing category
ANDA
Marketing start
2014-01-01
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
No
Listing certified through
2021-12-31
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
61919-535-602023-01-30C16284748780-1f386c649-d381-0266-e053-dadaa90a7c1aVENLAFAXINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-535-30VENLAFAXINE30 in 1 BOTTLETABLET303
61919-535-60VENLAFAXINE60 in 1 BOTTLETABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-535-30EA - Each61919-5357b89fd89-b469-4d8b-9863-f86baeb031f612014-07-02
61919-535-60EA - Each61919-535605b41bc-a6c2-4b26-9f7e-a528fb3c023b12014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE TABLET [DIRECT RX]1
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE TABLET [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VENLAFAXINE TABLET [DIRECT RX]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8VENLAFAXINE TABLET [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVENLAFAXINE TABLET [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VENLAFAXINE TABLET [DIRECT RX]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVENLAFAXINE TABLET [DIRECT RX]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EVENLAFAXINE TABLET [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-535VENLAFAXINE TABLET [DIRECT RX]3Legacy NDC, 2 package rows20200131_6490e629-062b-4caa-a0aa-3d9c75c693d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313586venlafaxine HCl 75 MG Oral TabletPSN6490e629-062b-4caa-a0aa-3d9c75c693d73
313586venlafaxine 75 MG Oral TabletSCD6490e629-062b-4caa-a0aa-3d9c75c693d73
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY6490e629-062b-4caa-a0aa-3d9c75c693d73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-535-306191905353030 in 1 BOTTLEHistorical
61919-535-606191905356060 BOTTLE in 1 BOTTLE (61919-535-60) > 30 TABLET in 1 BOTTLE (61919-535-30) 60 bottle2014-03-270000-00-00NoNoCurrent