FDA.reportPublic FDA data

DESVENLAFAXINE

Product NDC
50090-7190
11-digit product format
500907190
Labeler code
50090
Product ID
50090-7190_f397c250-cafe-4e23-b2d1-6aa31063eb0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DESVENLAFAXINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204028
Marketing category
ANDA
Marketing start
2022-01-31
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
50090-7190-0DESVENLAFAXINE30 in 1 PACKAGETABLET, EXTENDED RELEASE305
50090-7190-1DESVENLAFAXINE90 in 1 BOTTLETABLET, EXTENDED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7190-0EA - Each50090-7190e1c8b8f5-cadc-4639-866d-e6907237f16212024-08-12
50090-7190-1EA - Each50090-719043e27fdb-4a5b-4942-a24e-989104e6776412025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7190DESVENLAFAXINE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20240712_b14695b4-c35e-4902-8144-d31d698b1c58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1607617desvenlafaxine succinate 25 MG 24HR Extended Release Oral TabletPSNb14695b4-c35e-4902-8144-d31d698b1c585
160761724 HR desvenlafaxine succinate 25 MG Extended Release Oral TabletSCDb14695b4-c35e-4902-8144-d31d698b1c585
1607617desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral TabletSYb14695b4-c35e-4902-8144-d31d698b1c585

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7190-05009071900030 TABLET, EXTENDED RELEASE in 1 PACKAGE (50090-7190-0) 2024-07-08NoNoHistorical
50090-7190-15009071900190 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-7190-1) 2025-07-16NoNoHistorical