FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
45865-643
11-digit product format
458650643
Labeler code
45865
Product ID
45865-643_9ab35ec5-4dd6-d09d-e053-2a95a90a2fa8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
NDA020699
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2011-06-10
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
No
Listing certified through
2020-12-31
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
45865-643-302025-01-30C16284748780-12cef2736-5c9b-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE. Venlafaxine hydrochloride Extended-Release Capsules Initial U.S. Approval: 1997
45865-643-602025-01-30C16284748780-12cef2736-5c9b-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE. Venlafaxine hydrochloride Extended-Release Capsules Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-643-30Venlafaxine Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE303
45865-643-60Venlafaxine Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE603

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2
ETHYLCELLULOSE (100 MPA.S)INACTIVE INGREDIENT47MLB0F1MVVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2
GELATININACTIVE INGREDIENT2G86QN327LVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-643VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]3Legacy NDC, 2 package rows20191228_1f808a76-4837-687f-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN1f808a76-4837-687f-e054-00144ff88e883
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN1f808a76-4837-687f-e054-00144ff88e883
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD1f808a76-4837-687f-e054-00144ff88e883
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD1f808a76-4837-687f-e054-00144ff88e883
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY1f808a76-4837-687f-e054-00144ff88e883
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY1f808a76-4837-687f-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-643-304586506433030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (45865-643-30) 2015-09-110000-00-00NoNoCurrent
45865-643-604586506436060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (45865-643-60) 2015-09-110000-00-00NoNoCurrent