FDA.reportPublic FDA data

Venlafaxine

Product NDC
50090-4865
11-digit product format
500904865
Labeler code
50090
Product ID
50090-4865_47cfd5a6-1c1a-4e5f-97f5-9ab1c7b218a4
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
37.5 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 HYDROCHLORIDE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313584

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
50090-4865-02023-02-07C16284748780-1f386c64a-3ead-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP
50090-4865-12023-02-07C16284748780-1f386c64a-3ead-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP
50090-4865-02023-01-30C16284748780-1f386c64a-3ead-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP
50090-4865-12023-01-30C16284748780-1f386c64a-3ead-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4865-0Venlafaxine30 in 1 BOTTLETABLET308
50090-4865-1Venlafaxine90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4865-0EA - Each50090-4865303173cf-577d-49fa-a123-bbdd9ceff77f12025-06-13
50090-4865-1EA - Each50090-486558ee41db-2e0e-41c7-9dc5-8769cd246d7812025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4865VENLAFAXINE TABLET [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 2 package rows20250516_7bbdc9c5-a4b9-44d4-babc-46bd8c2e084a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313584venlafaxine HCl 37.5 MG Oral TabletPSN7bbdc9c5-a4b9-44d4-babc-46bd8c2e084a8
313584venlafaxine 37.5 MG Oral TabletSCD7bbdc9c5-a4b9-44d4-babc-46bd8c2e084a8
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY7bbdc9c5-a4b9-44d4-babc-46bd8c2e084a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4865-05009048650030 TABLET in 1 BOTTLE (50090-4865-0) 30 tablet2020-01-230000-00-00NoNoCurrent
50090-4865-15009048650190 TABLET in 1 BOTTLE (50090-4865-1) 90 tablet2020-01-230000-00-00NoNoCurrent