FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
68071-2704
11-digit product format
680712704
Labeler code
68071
Product ID
68071-2704_df60a465-444f-ec26-e053-2995a90a229a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA204003
Marketing category
ANDA
Marketing start
2017-03-01
Marketing end
0000-00-00
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
2023-12-31
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
68071-2704-32025-01-30C16284748780-12cef2736-a689-d83d-e063-dadaa90ab31fThese 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
68071-2704-3Desvenlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2704DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20220520_df60a82e-0d1e-6cc8-e053-2995a90a9ba4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSNdf60a82e-0d1e-6cc8-e053-2995a90a9ba41
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCDdf60a82e-0d1e-6cc8-e053-2995a90a9ba41
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSYdf60a82e-0d1e-6cc8-e053-2995a90a9ba41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2704-36807127040330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-2704-3) 2022-05-190000-00-00NoNoCurrent