FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
50090-5274
11-digit product format
500905274
Labeler code
50090
Product ID
50090-5274_ac2b33e3-45e5-4061-a50f-5615a310d9a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204003
Marketing category
ANDA
Marketing start
2018-11-28
Substance
DESVENLAFAXINE SUCCINATE
Active strength
25 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 SUCCINATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZB22ENF0XR
Rxcui1607617

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
50090-5274-02023-02-07C16284748780-1f386c64a-0327-0266-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
50090-5274-02023-01-30C16284748780-1f386c64a-0327-0266-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
50090-5274-0Desvenlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5274-0EA - Each50090-52742b01c407-5aef-4d28-9a4b-15b27e2bb5f712023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5274DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 1 package rows20230219_b2a3edb8-ba64-4ead-b452-d6c8dbaba91d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1607617desvenlafaxine succinate 25 MG 24HR Extended Release Oral TabletPSNb2a3edb8-ba64-4ead-b452-d6c8dbaba91d5
160761724 HR desvenlafaxine succinate 25 MG Extended Release Oral TabletSCDb2a3edb8-ba64-4ead-b452-d6c8dbaba91d5
1607617desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral TabletSYb2a3edb8-ba64-4ead-b452-d6c8dbaba91d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5274-05009052740030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5274-0) 2020-10-200000-00-00NoNoCurrent