FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
71335-2130
11-digit product format
713352130
Labeler code
71335
Product ID
71335-2130_0a83e29f-88b7-41c5-a014-b99e10a34ed9
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
2018-11-28
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
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 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
71335-2130-1Desvenlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE30104
71335-2130-2Desvenlafaxine60 in 1 BOTTLETABLET, EXTENDED RELEASE60104
71335-2130-3Desvenlafaxine90 in 1 BOTTLETABLET, EXTENDED RELEASE90104
71335-2130-4Desvenlafaxine120 in 1 BOTTLETABLET, EXTENDED RELEASE120104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2130-1EA - Each71335-2130ad2023f8-7a9c-4858-b73d-1541dec75b4212023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2130DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 4 package rows20241122_5e78c812-7fe6-4a4e-8465-0415df2e9851.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1607617desvenlafaxine succinate 25 MG 24HR Extended Release Oral TabletPSN5e78c812-7fe6-4a4e-8465-0415df2e9851104
160761724 HR desvenlafaxine succinate 25 MG Extended Release Oral TabletSCD5e78c812-7fe6-4a4e-8465-0415df2e9851104
1607617desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral TabletSY5e78c812-7fe6-4a4e-8465-0415df2e9851104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2130-17133521300130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2130-1) 2022-07-190000-00-00NoNoCurrent
71335-2130-27133521300260 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2130-2) 2023-03-130000-00-00NoNoCurrent
71335-2130-37133521300390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2130-3) 2024-11-010000-00-00NoNoCurrent
71335-2130-471335213004120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2130-4) 2024-11-010000-00-00NoNoCurrent