FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
67046-320
11-digit product format
670460320
Labeler code
67046
Product ID
67046-320_b05ffc2e-488a-6810-e053-2a95a90a7318
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA200834
Marketing category
ANDA
Marketing start
2020-04-15
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
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-320-302022-01-28C16284748780-1d6a99b39-e2be-a426-e053-dadaa90af4c2These 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
67046-320-30Venlafaxine Hydrochloride30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-320VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20200929_b0605e82-ed83-a82e-e053-2995a90a5537.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNb0605e82-ed83-a82e-e053-2995a90a55371
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNb0605e82-ed83-a82e-e053-2995a90a55371
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDb0605e82-ed83-a82e-e053-2995a90a55371
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDb0605e82-ed83-a82e-e053-2995a90a55371
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYb0605e82-ed83-a82e-e053-2995a90a55371
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYb0605e82-ed83-a82e-e053-2995a90a55371

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-320-306704603203030 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (67046-320-30) 2020-04-150000-00-00NoNoCurrent