FDA.reportPublic FDA data

DESVENLAFAXINE

Product NDC
72603-555
11-digit product format
726030555
Labeler code
72603
Product ID
72603-555_34888df6-f68d-c171-e063-6294a90a7604
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DESVENLAFAXINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA204028
Marketing category
ANDA
Marketing start
2025-05-02
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, 1874553, 1874559

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
72603-555-01DESVENLAFAXINE30 in 1 PACKAGETABLET, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-555-01EA - Each72603-5555e04388b-d334-494e-912c-27f0a87ba89312025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-555DESVENLAFAXINE TABLET, EXTENDED RELEASE [NORTHSTAR RX LLC]1Current NDC, 1 package rows20250508_3fcc0555-f9cf-4735-a0ef-830c50c390b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSN3fcc0555-f9cf-4735-a0ef-830c50c390b81
1607617desvenlafaxine succinate 25 MG 24HR Extended Release Oral TabletPSN3fcc0555-f9cf-4735-a0ef-830c50c390b81
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN3fcc0555-f9cf-4735-a0ef-830c50c390b81
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCD3fcc0555-f9cf-4735-a0ef-830c50c390b81
160761724 HR desvenlafaxine succinate 25 MG Extended Release Oral TabletSCD3fcc0555-f9cf-4735-a0ef-830c50c390b81
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD3fcc0555-f9cf-4735-a0ef-830c50c390b81
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSY3fcc0555-f9cf-4735-a0ef-830c50c390b81
1607617desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral TabletSY3fcc0555-f9cf-4735-a0ef-830c50c390b81
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY3fcc0555-f9cf-4735-a0ef-830c50c390b81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72603-555-017260305550130 TABLET, EXTENDED RELEASE in 1 PACKAGE (72603-555-01) 2025-05-02NoNoCurrent