FDA.reportPublic FDA data

Desvenlafaxine Succinate

Product NDC
50090-6894
11-digit product format
500906894
Labeler code
50090
Product ID
50090-6894_3d224100-79ea-4a95-b679-4c950017faf3
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
2017-03-01
Substance
DESVENLAFAXINE SUCCINATE
Active strength
50 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 SUCCINATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZB22ENF0XR
Rxcui1874559

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
50090-6894-0Desvenlafaxine Succinate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6894-0EA - Each50090-68942fec9bb3-69ec-478f-9756-8d7e162bfdf312024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6894DESVENLAFAXINE SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20231216_5755f1b2-c10b-47f6-a08d-38d1c05bd353.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN5755f1b2-c10b-47f6-a08d-38d1c05bd3534
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD5755f1b2-c10b-47f6-a08d-38d1c05bd3534
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY5755f1b2-c10b-47f6-a08d-38d1c05bd3534

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6894-05009068940030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-6894-0) 2023-12-07NoNoHistorical