FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
0054-0401
11-digit product format
000540401
Labeler code
0054
Product ID
0054-0401_c5148154-683f-4369-bb65-9f6f43a64e2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA204083
Marketing category
ANDA
Marketing start
2017-03-01
Substance
DESVENLAFAXINE SUCCINATE
Active strength
100 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 SUCCINATE100 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-0401-06Desvenlafaxine14 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1411
0054-0401-13Desvenlafaxine30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3011
0054-0401-20Desvenlafaxine10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE1011
0054-0401-20Desvenlafaxine10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE1011
0054-0401-22Desvenlafaxine90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0401-13EA - Each0054-040129a6dd19-e4ba-4a22-a335-5c8cb274bbd712017-04-05
0054-0401-22EA - Each0054-040141b90446-8726-4c21-8292-58f9a4ea980e12017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0401DESVENLAFAXINE TABLET, FILM COATED, EXTENDED RELEASE [HIKMA PHARMACEUTICALS USA INC.]10Current NDC, Legacy NDC, 5 package rows20241212_662890ff-d254-40e0-a9fe-f07ab94d65d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSN662890ff-d254-40e0-a9fe-f07ab94d65d611
1607617desvenlafaxine succinate 25 MG 24HR Extended Release Oral TabletPSN662890ff-d254-40e0-a9fe-f07ab94d65d611
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN662890ff-d254-40e0-a9fe-f07ab94d65d611
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCD662890ff-d254-40e0-a9fe-f07ab94d65d611
160761724 HR desvenlafaxine succinate 25 MG Extended Release Oral TabletSCD662890ff-d254-40e0-a9fe-f07ab94d65d611
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD662890ff-d254-40e0-a9fe-f07ab94d65d611
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSY662890ff-d254-40e0-a9fe-f07ab94d65d611
1607617desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral TabletSY662890ff-d254-40e0-a9fe-f07ab94d65d611
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY662890ff-d254-40e0-a9fe-f07ab94d65d611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0054-0401-060005404010614 in 1 BOTTLEHistorical
0054-0401-130005404011330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0401-13) 2017-03-010000-00-00NoNoCurrent
0054-0401-200005404012010 in 1 BLISTER PACKHistorical
0054-0401-220005404012290 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0401-22) 2017-03-010000-00-00NoNoCurrent