FDA.reportPublic FDA data

venlafaxine hydrochloride

Product NDC
58118-0335
11-digit product format
581180335
Labeler code
58118
Product ID
58118-0335_b0269a27-0f90-5cd5-e053-2995a90ad172
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA090174
Marketing category
ANDA
Marketing start
2019-10-08
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
75 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
2021-12-31
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
58118-0335-82024-01-30C16284748780-11030e364-ffa7-111a-e063-dadaa90a10e2These 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
58118-0335-8venlafaxine hydrochloride30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-0335VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2Legacy NDC, 1 package rows20200926_0da9518a-52f9-4cef-84c4-a82779ea6eed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN0da9518a-52f9-4cef-84c4-a82779ea6eed2
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD0da9518a-52f9-4cef-84c4-a82779ea6eed2
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY0da9518a-52f9-4cef-84c4-a82779ea6eed2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58118-0335-85811803350830 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (58118-0335-8) 2019-10-080000-00-00NoNoCurrent