FDA.reportPublic FDA data

Desvenlafaxine Succinate

Product NDC
50090-7468
11-digit product format
500907468
Labeler code
50090
Product ID
50090-7468_eb3e20e5-d136-463c-80ab-3d8fc16e0171
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine Succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Desvenlafaxine Succinate
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
50090-7468-0Desvenlafaxine Succinate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301
50090-7468-1Desvenlafaxine Succinate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7468-0EA - Each50090-7468ef07cc18-0a9e-4b07-84e2-78719553d63812025-01-14
50090-7468-1EA - Each50090-7468b322d373-c272-4656-af99-31e0b8e47eb612025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7468DESVENLAFAXINE SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20241207_7ee04e8c-ce6c-450d-9122-2bffd170bfd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1607617desvenlafaxine succinate 25 MG 24HR Extended Release Oral TabletPSN7ee04e8c-ce6c-450d-9122-2bffd170bfd71
160761724 HR desvenlafaxine succinate 25 MG Extended Release Oral TabletSCD7ee04e8c-ce6c-450d-9122-2bffd170bfd71
1607617desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral TabletSY7ee04e8c-ce6c-450d-9122-2bffd170bfd71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7468-05009074680030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-7468-0) 2024-12-03NoNoCurrent
50090-7468-15009074680190 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-7468-1) 2024-12-03NoNoCurrent