FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
35208-011
11-digit product format
352080011
Labeler code
35208
Product ID
35208-011_7aa12522-2287-4a9e-a8bf-0c87eb98aa03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
IntelliPharmaCeutics Corp.
Application
ANDA201272
Marketing category
ANDA
Marketing start
2018-12-03
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
35208-011-102020-01-31C16284748780-19d75b9d1-0d77-f424-e053-dadaa90a57ceThese 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
35208-011-152020-01-31C16284748780-19d75b9d1-0d77-f424-e053-dadaa90a57ceThese 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
35208-011-10Venlafaxine Hydrochloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10009
35208-011-15Venlafaxine Hydrochloride15 in 1 BOTTLECAPSULE, EXTENDED RELEASE159

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35208-011VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [INTELLIPHARMACEUTICS CORP.]9Legacy NDC, 2 package rows20181206_03fe662f-9047-4e61-93a2-1565e34f106f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN03fe662f-9047-4e61-93a2-1565e34f106f9
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN03fe662f-9047-4e61-93a2-1565e34f106f9
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN03fe662f-9047-4e61-93a2-1565e34f106f9
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD03fe662f-9047-4e61-93a2-1565e34f106f9
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD03fe662f-9047-4e61-93a2-1565e34f106f9
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD03fe662f-9047-4e61-93a2-1565e34f106f9
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY03fe662f-9047-4e61-93a2-1565e34f106f9
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY03fe662f-9047-4e61-93a2-1565e34f106f9
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY03fe662f-9047-4e61-93a2-1565e34f106f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
35208-011-10352080011101000 in 1 BOTTLEHistorical
35208-011-153520800111515 in 1 BOTTLEHistorical