FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
71205-586
11-digit product format
712050586
Labeler code
71205
Product ID
71205-586_39cdc974-0387-41dd-946b-4f8b77066ff5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204003
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
Rxcui1874553

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
71205-586-30Desvenlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE302
71205-586-60Desvenlafaxine60 in 1 BOTTLETABLET, EXTENDED RELEASE602
71205-586-90Desvenlafaxine90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-586DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20230211_d4542c5e-f9e8-49c7-afa6-9dd4c4d485f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSNd4542c5e-f9e8-49c7-afa6-9dd4c4d485f22
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCDd4542c5e-f9e8-49c7-afa6-9dd4c4d485f22
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSYd4542c5e-f9e8-49c7-afa6-9dd4c4d485f22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-586-307120505863030 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-586-30) 2021-07-070000-00-00NoNoCurrent
71205-586-607120505866060 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-586-60) 2021-07-070000-00-00NoNoCurrent
71205-586-907120505869090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-586-90) 2021-07-070000-00-00NoNoCurrent