FDA.reportPublic FDA data

Desvenlafaxine Succinate

Product NDC
71335-2494
11-digit product format
713352494
Labeler code
71335
Product ID
71335-2494_54f24fe2-06df-48a2-8646-56f23a153a57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine Succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204172
Marketing category
ANDA
Marketing start
2022-08-25
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 Succinate
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
99b326f2-4886-9fc8-8686-faef7b7f27ddProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2494-1Desvenlafaxine Succinate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE302
71335-2494-2Desvenlafaxine Succinate60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE602
71335-2494-3Desvenlafaxine Succinate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE902
71335-2494-4Desvenlafaxine Succinate120 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2494DESVENLAFAXINE SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]1Current NDC, 4 package rows20240920_5f349cc5-b803-462d-b323-d681bd1a02f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1607617desvenlafaxine succinate 25 MG 24HR Extended Release Oral TabletPSN5f349cc5-b803-462d-b323-d681bd1a02f02
160761724 HR desvenlafaxine succinate 25 MG Extended Release Oral TabletSCD5f349cc5-b803-462d-b323-d681bd1a02f02
1607617desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral TabletSY5f349cc5-b803-462d-b323-d681bd1a02f02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2494-17133524940130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2494-1) 2024-09-16NoNoCurrent
71335-2494-27133524940260 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2494-2) 2024-09-16NoNoCurrent
71335-2494-37133524940390 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2494-3) 2024-09-16NoNoCurrent
71335-2494-471335249404120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2494-4) 2024-09-16NoNoCurrent