FDA.reportPublic FDA data

Venlafaxine

Product NDC
50090-2408
11-digit product format
500902408
Labeler code
50090
Product ID
50090-2408_5839cd0a-2686-4b5c-9cf3-7992978d5146
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077653
Marketing category
ANDA
Marketing start
2008-06-13
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
50090-2408-02023-02-07C16284748780-1f386c64a-1ba9-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP
50090-2408-12023-02-07C16284748780-1f386c64a-1ba9-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP
50090-2408-02023-01-30C16284748780-1f386c64a-1ba9-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP
50090-2408-12023-01-30C16284748780-1f386c64a-1ba9-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2408-0Venlafaxine30 in 1 BOTTLETABLET308
50090-2408-1Venlafaxine90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2408-0EA - Each50090-2408b9aeee43-2793-46b3-a817-7907300bdc8812021-09-07
50090-2408-1EA - Each50090-240817f6004a-7316-4d0a-9b6e-9601ce43ba8612021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2408VENLAFAXINE TABLET [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 2 package rows20230511_d3475ce0-1368-4961-a9b9-44c5c33cdc58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313586venlafaxine HCl 75 MG Oral TabletPSNd3475ce0-1368-4961-a9b9-44c5c33cdc588
313586venlafaxine 75 MG Oral TabletSCDd3475ce0-1368-4961-a9b9-44c5c33cdc588
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSYd3475ce0-1368-4961-a9b9-44c5c33cdc588

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2408-05009024080030 TABLET in 1 BOTTLE (50090-2408-0) 30 tablet2016-05-190000-00-00NoNoCurrent
50090-2408-15009024080190 TABLET in 1 BOTTLE (50090-2408-1) 90 tablet2016-05-190000-00-00NoNoCurrent