FDA.reportPublic FDA data

venlafaxine

Product NDC
50090-4715
11-digit product format
500904715
Labeler code
50090
Product ID
50090-4715_71227eaa-30c6-43df-b625-f2afeb3a4cbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4715-02024-12-04C16284748780-1f386c64a-2845-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP Rx only
50090-4715-12024-12-04C16284748780-1f386c64a-2845-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP Rx only
50090-4715-02023-01-30C16284748780-1f386c64a-2845-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP Rx only
50090-4715-12023-01-30C16284748780-1f386c64a-2845-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4715-0venlafaxine30 in 1 BOTTLETABLET305
50090-4715-1venlafaxine90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4715VENLAFAXINE TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20241205_ab58f3ef-1fd3-4c68-861f-20d8fdd1b433.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313586venlafaxine HCl 75 MG Oral TabletPSNab58f3ef-1fd3-4c68-861f-20d8fdd1b4335
313586venlafaxine 75 MG Oral TabletSCDab58f3ef-1fd3-4c68-861f-20d8fdd1b4335
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSYab58f3ef-1fd3-4c68-861f-20d8fdd1b4335

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4715-05009047150030 TABLET in 1 BOTTLE (50090-4715-0) 30 tablet2019-11-120000-00-00NoNoCurrent
50090-4715-15009047150190 TABLET in 1 BOTTLE (50090-4715-1) 90 tablet2019-11-120000-00-00NoNoCurrent