FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
50090-4388
11-digit product format
500904388
Labeler code
50090
Product ID
50090-4388_721b15a8-8e34-4059-afb7-b914b86f0427
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204065
Marketing category
ANDA
Marketing start
2017-03-01
Marketing end
0000-00-00
Substance
DESVENLAFAXINE SUCCINATE
Active strength
25 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
2022-12-31
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
50090-4388-02023-01-30C16284748780-1f386c64a-3aa4-0266-e053-dadaa90a7c1aThese 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 -re lease tablets, for oral use Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4388-0Desvenlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4388-0EA - Each50090-43881e7ba5a1-e56b-4c00-8331-771247bb1c7f12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4388DESVENLAFAXINE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]5Legacy NDC, 1 package rows20210615_bbbb837b-7587-4870-870f-a5b14ade4e30.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1607617desvenlafaxine succinate 25 MG 24HR Extended Release Oral TabletPSNbbbb837b-7587-4870-870f-a5b14ade4e305
160761724 HR desvenlafaxine succinate 25 MG Extended Release Oral TabletSCDbbbb837b-7587-4870-870f-a5b14ade4e305
1607617desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral TabletSYbbbb837b-7587-4870-870f-a5b14ade4e305

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4388-05009043880030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4388-0) 2019-06-250000-00-00NoNoCurrent