FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
45865-864
11-digit product format
458650864
Labeler code
45865
Product ID
45865-864_9ab49fc8-f92d-9986-e053-2995a90ae187
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA076565
Marketing category
ANDA
Marketing start
2010-07-01
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
150 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
2020-12-31
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
45865-864-302023-01-30C16284748780-1f386c649-af35-0266-e053-dadaa90a7c1aThese 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
45865-864-30Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-864VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 1 package rows20191228_7dc8dbaa-3219-7b8b-e053-2a91aa0ac6ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN7dc8dbaa-3219-7b8b-e053-2a91aa0ac6ba2
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD7dc8dbaa-3219-7b8b-e053-2a91aa0ac6ba2
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY7dc8dbaa-3219-7b8b-e053-2a91aa0ac6ba2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-864-304586508643030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45865-864-30) 2018-06-010000-00-00NoNoCurrent