FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
63629-7525
11-digit product format
636297525
Labeler code
63629
Product ID
63629-7525_1070846d-21cb-48e3-8fe9-d93014c7840c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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
63629-7525-1Desvenlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE3016
63629-7525-2Desvenlafaxine28 in 1 BOTTLETABLET, EXTENDED RELEASE2816
63629-7525-3Desvenlafaxine60 in 1 BOTTLETABLET, EXTENDED RELEASE6016
63629-7525-4Desvenlafaxine90 in 1 BOTTLETABLET, EXTENDED RELEASE9016
63629-7525-5Desvenlafaxine180 in 1 BOTTLETABLET, EXTENDED RELEASE18016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-7525-1EA - Each63629-75250421a636-081b-4b80-a220-d1c85ce0caa712022-04-06
63629-7525-3EA - Each63629-7525e219ff59-ab55-46f6-acd6-cfae3530077712023-09-05
63629-7525-4EA - Each63629-7525137f579b-53fb-418e-a143-27bb50fcece312023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7525DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]16Current NDC, Legacy NDC, 5 package rows20241109_f99c78ef-5a0a-45af-9b4b-5a78b75fe994.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSNf99c78ef-5a0a-45af-9b4b-5a78b75fe99416
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCDf99c78ef-5a0a-45af-9b4b-5a78b75fe99416
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSYf99c78ef-5a0a-45af-9b4b-5a78b75fe99416

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7525-16362975250130 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7525-1) 2018-02-050000-00-00NoNoCurrent
63629-7525-26362975250228 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7525-2) 2018-04-270000-00-00NoNoCurrent
63629-7525-36362975250360 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7525-3) 2018-08-020000-00-00NoNoCurrent
63629-7525-46362975250490 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7525-4) 2022-02-100000-00-00NoNoCurrent
63629-7525-563629752505180 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7525-5) 2022-08-31NoNoHistorical