FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
53002-2365
11-digit product format
530022365
Labeler code
53002
Product ID
53002-2365_dc0859ba-c727-457c-b56c-17f956117390
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA200834
Marketing category
ANDA
Marketing start
2011-06-01
Marketing end
0000-00-00
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
2023-12-31
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
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-2365-32025-01-30C16284748780-12cef2736-9b72-d83d-e063-dadaa90ab31fThese 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, for oral use Initial U.S. Approval: 1997
53002-2365-92025-01-30C16284748780-12cef2736-9b72-d83d-e063-dadaa90ab31fThese 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, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2365-3Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
53002-2365-9Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2365VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 2 package rows20220331_dd4201bf-c845-4888-ada8-8506f04b89d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNdd4201bf-c845-4888-ada8-8506f04b89d81
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDdd4201bf-c845-4888-ada8-8506f04b89d81
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYdd4201bf-c845-4888-ada8-8506f04b89d81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-2365-35300223650330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53002-2365-3) 2021-01-010000-00-00NoNoCurrent
53002-2365-95300223650990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53002-2365-9) 2021-01-010000-00-00NoNoCurrent