FDA.reportPublic FDA data

venlafaxine

Product NDC
63187-752
11-digit product format
631870752
Labeler code
63187
Product ID
63187-752_0a1e4108-e2a9-4c22-ab48-900d3bc20c1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078932
Marketing category
ANDA
Marketing start
2015-10-01
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
venlafaxine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313580

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
63187-752-30venlafaxine30 in 1 BOTTLETABLET304
63187-752-60venlafaxine60 in 1 BOTTLETABLET604
63187-752-90venlafaxine90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-752VENLAFAXINE TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20200121_cc3a1258-aafb-48cf-86f7-fcf59e0c6cdd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313580venlafaxine HCl 100 MG Oral TabletPSNcc3a1258-aafb-48cf-86f7-fcf59e0c6cdd4
313580venlafaxine 100 MG Oral TabletSCDcc3a1258-aafb-48cf-86f7-fcf59e0c6cdd4
313580venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral TabletSYcc3a1258-aafb-48cf-86f7-fcf59e0c6cdd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-752-306318707523030 TABLET in 1 BOTTLE (63187-752-30) 30 tablet2016-10-030000-00-00NoNoCurrent
63187-752-606318707526060 TABLET in 1 BOTTLE (63187-752-60) 60 tablet2016-10-030000-00-00NoNoCurrent
63187-752-906318707529090 TABLET in 1 BOTTLE (63187-752-90) 90 tablet2016-10-030000-00-00NoNoCurrent