FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
46708-152
11-digit product format
467080152
Labeler code
46708
Product ID
46708-152_6ebe192e-2b88-43fc-a2c8-db2c42bc5a43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
NDA204150
Marketing category
NDA
Marketing start
2013-03-05
Substance
DESVENLAFAXINE
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
DESVENLAFAXINE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNG99554ANW
Rxcui790264, 790288

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
46708-152-302023-02-01C16284748780-1f386c649-c63d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DESVENLAFAXINE safely and effectively. See full prescribing information for DESVENLAFAXINE. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
46708-152-902023-02-01C16284748780-1f386c649-c63d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DESVENLAFAXINE safely and effectively. See full prescribing information for DESVENLAFAXINE. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
46708-152-302023-01-30C16284748780-1f386c649-c63d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DESVENLAFAXINE safely and effectively. See full prescribing information for DESVENLAFAXINE. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
46708-152-902023-01-30C16284748780-1f386c649-c63d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DESVENLAFAXINE safely and effectively. See full prescribing information for DESVENLAFAXINE. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-152-30Desvenlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE302
46708-152-90Desvenlafaxine90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-152DESVENLAFAXINE TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]2Current NDC, Legacy NDC, 2 package rows20230202_9f74708c-6f6a-46cf-8c79-87a25c2bb6f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
790264desvenlafaxine 100 MG 24HR Extended Release Oral TabletPSN9f74708c-6f6a-46cf-8c79-87a25c2bb6f82
790288desvenlafaxine 50 MG 24HR Extended Release Oral TabletPSN9f74708c-6f6a-46cf-8c79-87a25c2bb6f82
79026424 HR desvenlafaxine 100 MG Extended Release Oral TabletSCD9f74708c-6f6a-46cf-8c79-87a25c2bb6f82
79028824 HR desvenlafaxine 50 MG Extended Release Oral TabletSCD9f74708c-6f6a-46cf-8c79-87a25c2bb6f82
790264desvenlafaxine 100 MG 24 HR Extended Release Oral TabletSY9f74708c-6f6a-46cf-8c79-87a25c2bb6f82
790288desvenlafaxine 50 MG 24 HR Extended Release Oral TabletSY9f74708c-6f6a-46cf-8c79-87a25c2bb6f82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46708-152-304670801523030 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-152-30) 2013-03-050000-00-00NoNoCurrent
46708-152-904670801529090 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-152-90) 2013-03-050000-00-00NoNoCurrent