FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
50090-4806
11-digit product format
500904806
Labeler code
50090
Product ID
50090-4806_63c611a8-0cbe-4445-a075-65b6443166a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204082
Marketing category
ANDA
Marketing start
2017-03-01
Substance
DESVENLAFAXINE SUCCINATE
Active strength
50 mg/1
Pharmacologic classes
Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Desvenlafaxine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESVENLAFAXINE SUCCINATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZB22ENF0XR
Rxcui1874559

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
50090-4806-02023-02-06C16284748780-1f386c649-e9cd-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-release tablets, for oral use Initial U.S. Approval: 2008
50090-4806-02023-01-30C16284748780-1f386c649-e9cd-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-release tablets, for oral use Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4806-0Desvenlafaxine30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE309
50090-4806-1Desvenlafaxine90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4806-0EA - Each50090-4806311eb933-32c0-4ae2-9dfe-b870d7691cd612024-08-12
50090-4806-1EA - Each50090-4806272008d5-b444-4401-b8e8-1a0392a1bd0c12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4806DESVENLAFAXINE TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20241206_7107a864-fcb3-4cbf-9fcb-061bef13be2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN7107a864-fcb3-4cbf-9fcb-061bef13be2d9
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD7107a864-fcb3-4cbf-9fcb-061bef13be2d9
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY7107a864-fcb3-4cbf-9fcb-061bef13be2d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4806-05009048060030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4806-0) 2019-12-230000-00-00NoNoCurrent
50090-4806-15009048060190 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4806-1) 2024-11-26NoNoCurrent