FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
35208-009
11-digit product format
352080009
Labeler code
35208
Product ID
35208-009_271399b9-3ce8-4c09-a6e1-79e0ca27c344
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
IntelliPharmaCeutics Corp.
Application
ANDA204805
Marketing category
ANDA
Marketing start
2018-08-01
Marketing end
0000-00-00
Substance
DESVENLAFAXINE SUCCINATE
Active strength
50 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 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
a9aae381-3b13-08a9-c49d-484a2c2a6dc8Product name720251106
99b326f2-4886-9fc8-8686-faef7b7f27ddProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
35208-009-102021-01-29C16284748780-1ba0f9c33-1c82-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
35208-009-142021-01-29C16284748780-1ba0f9c33-1c82-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35208-009-10Desvenlafaxine1000 in 1 BOTTLETABLET, EXTENDED RELEASE10006
35208-009-14Desvenlafaxine14 in 1 BOTTLETABLET, EXTENDED RELEASE146

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35208-009DESVENLAFAXINE TABLET, EXTENDED RELEASE [INTELLIPHARMACEUTICS CORP.]6Legacy NDC, 2 package rows20190525_dab59220-a4de-4a0d-aaa6-e19dbfda1e15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSNdab59220-a4de-4a0d-aaa6-e19dbfda1e156
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSNdab59220-a4de-4a0d-aaa6-e19dbfda1e156
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCDdab59220-a4de-4a0d-aaa6-e19dbfda1e156
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCDdab59220-a4de-4a0d-aaa6-e19dbfda1e156
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSYdab59220-a4de-4a0d-aaa6-e19dbfda1e156
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSYdab59220-a4de-4a0d-aaa6-e19dbfda1e156

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
35208-009-10352080009101000 in 1 BOTTLEHistorical
35208-009-143520800091414 in 1 BOTTLEHistorical