FDA.reportPublic FDA data

VENLAFAXINE HYDROCHLORIDE

Product NDC
50090-3084
11-digit product format
500903084
Labeler code
50090
Product ID
50090-3084_b221f5c9-96ac-4678-8b2d-5e0a5d7e9b2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090899
Marketing category
ANDA
Marketing start
2011-01-06
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
38 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
17db3736-056c-48b9-b0f4-00fccabb14e6Product name520251118
7be8b949-f2c0-bdd8-e89d-8af92c1b2eadProduct name920250224
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3084-02020-01-31C16284748780-19d75b9d0-62e6-f424-e053-dadaa90a57ceHIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE hydrochloride extended-release capsules, USP, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3084-0VENLAFAXINE HYDROCHLORIDE33 in 1 BOX, UNIT-DOSECAPSULE, EXTENDED RELEASE335
50090-3084-0VENLAFAXINE HYDROCHLORIDE1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3084-0EA - Each50090-30845b8e6488-0213-4cb8-b473-f856ee06f17812021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3084VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]5Legacy NDC, 2 package rows20180820_1d18073e-541e-495e-8793-d4f386609f81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN1d18073e-541e-495e-8793-d4f386609f815
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD1d18073e-541e-495e-8793-d4f386609f815
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY1d18073e-541e-495e-8793-d4f386609f815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-3084-05009030840033 in 1 BOX, UNIT-DOSEHistorical