FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
0615-8346
11-digit product format
006158346
Labeler code
0615
Product ID
0615-8346_41a6941d-eb7b-4a2c-a46c-90e6e7b0aa2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA076690
Marketing category
ANDA
Marketing start
2006-08-04
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 Hydrochloride
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
0615-8346-39Venlafaxine Hydrochloride30 in 1 BLISTER PACKTABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8346VENLAFAXINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]2Current NDC, Legacy NDC, 1 package rows20221220_3eef522f-9e95-4668-bb12-09fd47ed0daf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313586venlafaxine HCl 75 MG Oral TabletPSN3eef522f-9e95-4668-bb12-09fd47ed0daf2
313586venlafaxine 75 MG Oral TabletSCD3eef522f-9e95-4668-bb12-09fd47ed0daf2
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY3eef522f-9e95-4668-bb12-09fd47ed0daf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8346-390061583463930 TABLET in 1 BLISTER PACK (0615-8346-39) 30 tablet2020-07-220000-00-00NoNoCurrent