FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
63187-223
11-digit product format
631870223
Labeler code
63187
Product ID
63187-223_ea0f0a8f-c9a3-4acb-8d8f-2adcbaa0779c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA020699
Marketing category
ANDA
Marketing start
2011-06-10
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
150 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
2019-12-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-223-30Venlafaxine Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE301
63187-223-90Venlafaxine Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE901

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
ETHYLCELLULOSE (100 MPA.S)INACTIVE INGREDIENT47MLB0F1MVVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
GELATININACTIVE INGREDIENT2G86QN327LVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-223VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1Legacy NDC, 2 package rows20150609_cff6a737-3917-4323-8e36-3acc5574a2cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNcff6a737-3917-4323-8e36-3acc5574a2cd1
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNcff6a737-3917-4323-8e36-3acc5574a2cd1
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDcff6a737-3917-4323-8e36-3acc5574a2cd1
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDcff6a737-3917-4323-8e36-3acc5574a2cd1
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYcff6a737-3917-4323-8e36-3acc5574a2cd1
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYcff6a737-3917-4323-8e36-3acc5574a2cd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63187-223-306318702233030 in 1 BOTTLE, PLASTICHistorical
63187-223-906318702239090 in 1 BOTTLE, PLASTICHistorical