FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
46708-540
11-digit product format
467080540
Labeler code
46708
Product ID
46708-540_162ec8ed-f695-4db2-badf-4afb6b9e1cba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA204003
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
Rxcui1607617, 1874553, 1874559

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
46708-540-102023-02-01C16284748780-1f386c64a-2b96-0266-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
46708-540-172023-02-01C16284748780-1f386c64a-2b96-0266-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
46708-540-302023-02-01C16284748780-1f386c64a-2b96-0266-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
46708-540-312023-02-01C16284748780-1f386c64a-2b96-0266-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
46708-540-802023-02-01C16284748780-1f386c64a-2b96-0266-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
46708-540-902023-02-01C16284748780-1f386c64a-2b96-0266-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
46708-540-912023-02-01C16284748780-1f386c64a-2b96-0266-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
46708-540-102023-01-30C16284748780-1f386c64a-2b96-0266-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
46708-540-172023-01-30C16284748780-1f386c64a-2b96-0266-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
46708-540-302023-01-30C16284748780-1f386c64a-2b96-0266-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
46708-540-312023-01-30C16284748780-1f386c64a-2b96-0266-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
46708-540-802023-01-30C16284748780-1f386c64a-2b96-0266-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
46708-540-902023-01-30C16284748780-1f386c64a-2b96-0266-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
46708-540-912023-01-30C16284748780-1f386c64a-2b96-0266-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
46708-540-10Desvenlafaxine100 in 1 CARTONTABLET, EXTENDED RELEASE1005
46708-540-17Desvenlafaxine14 in 1 BOTTLETABLET, EXTENDED RELEASE145
46708-540-30Desvenlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE305
46708-540-31Desvenlafaxine100 in 1 BOTTLETABLET, EXTENDED RELEASE1005
46708-540-80Desvenlafaxine80 in 1 CARTONTABLET, EXTENDED RELEASE805
46708-540-90Desvenlafaxine90 in 1 BOTTLETABLET, EXTENDED RELEASE905
46708-540-91Desvenlafaxine1000 in 1 BOTTLETABLET, EXTENDED RELEASE10005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-540DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]5Current NDC, Legacy NDC, 7 package rows20230202_5bd203d2-477e-4d12-a875-cb8009f42410.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSN5bd203d2-477e-4d12-a875-cb8009f424105
1607617desvenlafaxine succinate 25 MG 24HR Extended Release Oral TabletPSN5bd203d2-477e-4d12-a875-cb8009f424105
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN5bd203d2-477e-4d12-a875-cb8009f424105
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCD5bd203d2-477e-4d12-a875-cb8009f424105
160761724 HR desvenlafaxine succinate 25 MG Extended Release Oral TabletSCD5bd203d2-477e-4d12-a875-cb8009f424105
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD5bd203d2-477e-4d12-a875-cb8009f424105
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSY5bd203d2-477e-4d12-a875-cb8009f424105
1607617desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral TabletSY5bd203d2-477e-4d12-a875-cb8009f424105
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY5bd203d2-477e-4d12-a875-cb8009f424105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46708-540-1046708054010100 TABLET, EXTENDED RELEASE in 1 CARTON (46708-540-10) 2017-03-010000-00-00NoNoCurrent
46708-540-174670805401714 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-540-17) 2017-03-010000-00-00NoNoCurrent
46708-540-304670805403030 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-540-30) 2017-03-010000-00-00NoNoCurrent
46708-540-3146708054031100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-540-31) 2017-03-010000-00-00NoNoCurrent
46708-540-804670805408080 TABLET, EXTENDED RELEASE in 1 CARTON (46708-540-80) 2017-03-010000-00-00NoNoCurrent
46708-540-904670805409090 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-540-90) 2017-03-010000-00-00NoNoCurrent
46708-540-91467080540911000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-540-91) 2017-03-010000-00-00NoNoCurrent