FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
68151-5295
11-digit product format
681515295
Labeler code
68151
Product ID
68151-5295_bfa1c283-a45a-465b-bfec-39a002e58466
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
desvenlafaxine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA204095
Marketing category
ANDA
Marketing start
2017-03-01
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
2019-12-31
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
68151-5295-12020-01-31C16284748780-19d75b9d0-ec5f-f424-e053-dadaa90a57ceThese 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
68151-5295-1Desvenlafaxine1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-5295DESVENLAFAXINE TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]4Legacy NDC, 1 package rows20180207_c05fd27e-21a1-4497-8287-b09ea82433c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSNc05fd27e-21a1-4497-8287-b09ea82433c24
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCDc05fd27e-21a1-4497-8287-b09ea82433c24
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSYc05fd27e-21a1-4497-8287-b09ea82433c24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-5295-1681515295011 in 1 BLISTER PACKHistorical