Desvenlafaxine

Product NDC
67046-1545
11-digit product format
670461545
Labeler code
67046
Product ID
67046-1545_325bf247-8b58-9ef6-e063-6294a90ac9bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Coupler LLC
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
67046-1545-3Desvenlafaxine30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1545DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [COUPLER LLC]1Current NDC, 1 package rows20250410_325be002-4db2-40e9-e063-6394a90ae94e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSN325be002-4db2-40e9-e063-6394a90ae94e1
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCD325be002-4db2-40e9-e063-6394a90ae94e1
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSY325be002-4db2-40e9-e063-6394a90ae94e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67046-1545-36704615450330 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1545-3) 2025-04-09NoNoHistorical