FDA.reportPublic FDA data

DESVENLAFAXINE

Product NDC
71335-2490
11-digit product format
713352490
Labeler code
71335
Product ID
71335-2490_78845353-6efc-47ce-a1b4-0b5b6dfb2238
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DESVENLAFAXINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204028
Marketing category
ANDA
Marketing start
2022-01-31
Substance
DESVENLAFAXINE SUCCINATE
Active strength
25 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DESVENLAFAXINE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESVENLAFAXINE SUCCINATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZB22ENF0XR
Rxcui1607617

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
71335-2490-1DESVENLAFAXINE30 in 1 BOTTLETABLET, EXTENDED RELEASE302
71335-2490-2DESVENLAFAXINE60 in 1 BOTTLETABLET, EXTENDED RELEASE602
71335-2490-3DESVENLAFAXINE90 in 1 BOTTLETABLET, EXTENDED RELEASE902
71335-2490-4DESVENLAFAXINE120 in 1 BOTTLETABLET, EXTENDED RELEASE1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2490DESVENLAFAXINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1Current NDC, 4 package rows20240920_65f4a870-aa91-4d05-a32d-a161295bcc17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1607617desvenlafaxine succinate 25 MG 24HR Extended Release Oral TabletPSN65f4a870-aa91-4d05-a32d-a161295bcc172
160761724 HR desvenlafaxine succinate 25 MG Extended Release Oral TabletSCD65f4a870-aa91-4d05-a32d-a161295bcc172
1607617desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral TabletSY65f4a870-aa91-4d05-a32d-a161295bcc172

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2490-17133524900130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2490-1) 2024-09-18NoNoHistorical
71335-2490-27133524900260 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2490-2) 2024-09-18NoNoHistorical
71335-2490-37133524900390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2490-3) 2024-09-18NoNoHistorical
71335-2490-471335249004120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2490-4) 2024-09-18NoNoHistorical