FDA.reportPublic FDA data

Desvenlafaxine Succinate

Product NDC
50090-4069
11-digit product format
500904069
Labeler code
50090
Product ID
50090-4069_ce48638d-3ca2-48d8-af3b-532e0a60e654
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
desvenlafaxine succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA021992
Marketing category
NDA AUTHORIZED GENERIC
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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
99b326f2-4886-9fc8-8686-faef7b7f27ddProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4069-02023-01-30C16284748780-1f386c649-bd7f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DESVENLAFAXINE SUCCINATE safely and effectively. See full prescribing information for DESVENLAFAXINE SUCCINATE. Desvenlafaxine Succinate Extended-Release Tablets, for oral use Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4069-0Desvenlafaxine Succinate30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4069DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20190123_194cfe3f-7831-4eae-823c-bfc5c715a590.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN194cfe3f-7831-4eae-823c-bfc5c715a5901
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD194cfe3f-7831-4eae-823c-bfc5c715a5901
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY194cfe3f-7831-4eae-823c-bfc5c715a5901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4069-05009040690030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-4069-0) 2019-01-180000-00-00NoNoCurrent