FDA.reportPublic FDA data

venlafaxine

Product NDC
63187-929
11-digit product format
631870929
Labeler code
63187
Product ID
63187-929_3c9b5601-ee46-417a-8322-bda5a9ba48c6
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
75 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 HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313586

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
63187-929-30venlafaxine30 in 1 BOTTLETABLET305
63187-929-60venlafaxine60 in 1 BOTTLETABLET605
63187-929-90venlafaxine90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-929VENLAFAXINE TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20240720_ded77a84-e6d1-4471-ac6e-a05a0955daa5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313586venlafaxine HCl 75 MG Oral TabletPSNded77a84-e6d1-4471-ac6e-a05a0955daa55
313586venlafaxine 75 MG Oral TabletSCDded77a84-e6d1-4471-ac6e-a05a0955daa55
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSYded77a84-e6d1-4471-ac6e-a05a0955daa55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-929-306318709293030 TABLET in 1 BOTTLE (63187-929-30) 30 tablet2017-11-010000-00-00NoNoCurrent
63187-929-606318709296060 TABLET in 1 BOTTLE (63187-929-60) 60 tablet2017-11-010000-00-00NoNoCurrent
63187-929-906318709299090 TABLET in 1 BOTTLE (63187-929-90) 90 tablet2017-11-010000-00-00NoNoCurrent