FDA.reportPublic FDA data

venlafaxine

Product NDC
50090-4853
11-digit product format
500904853
Labeler code
50090
Product ID
50090-4853_4858b2b3-fa81-4906-b002-5bb1d3bb100b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090555
Marketing category
ANDA
Marketing start
2010-04-07
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
50090-4853-02023-02-07C16284748780-1f386c649-a4e5-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP Rx only
50090-4853-12023-02-07C16284748780-1f386c649-a4e5-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP Rx only
50090-4853-02023-01-30C16284748780-1f386c649-a4e5-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP Rx only
50090-4853-12023-01-30C16284748780-1f386c649-a4e5-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4853-0venlafaxine30 in 1 BOTTLETABLET305
50090-4853-1venlafaxine90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4853-0EA - Each50090-4853ec83d582-f0e8-4969-97a8-6b3c47d847b712024-08-12
50090-4853-1EA - Each50090-4853887bdf04-88a7-4728-8414-760340dfbc7012024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4853VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20230208_5bd03cf1-e8fc-44f3-9c41-06515b897f3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313584venlafaxine HCl 37.5 MG Oral TabletPSN5bd03cf1-e8fc-44f3-9c41-06515b897f3b5
313584venlafaxine 37.5 MG Oral TabletSCD5bd03cf1-e8fc-44f3-9c41-06515b897f3b5
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY5bd03cf1-e8fc-44f3-9c41-06515b897f3b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4853-05009048530030 TABLET in 1 BOTTLE (50090-4853-0) 30 tablet2020-01-200000-00-00NoNoCurrent
50090-4853-15009048530190 TABLET in 1 BOTTLE (50090-4853-1) 90 tablet2020-01-200000-00-00NoNoCurrent