FDA.reportPublic FDA data

desvenlafaxine

Product NDC
72189-147
11-digit product format
721890147
Labeler code
72189
Product ID
72189-147_2be9051e-2257-8882-e063-6294a90a543a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
desvenlafaxine succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA204003
Marketing category
ANDA
Marketing start
2020-11-12
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-147-28desvenlafaxine28 in 1 BOTTLETABLET, EXTENDED RELEASE283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-147DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [DIRECT RX]3Current NDC, Legacy NDC, 1 package rows20250119_b3ef2bb2-c336-2d57-e053-2995a90a5fe0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSNb3ef2bb2-c336-2d57-e053-2995a90a5fe03
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCDb3ef2bb2-c336-2d57-e053-2995a90a5fe03
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSYb3ef2bb2-c336-2d57-e053-2995a90a5fe03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-147-287218901472828 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-147-28) 2020-11-120000-00-00NoNoCurrent