FDA.reportPublic FDA data

DESVENLAFAXINE

Product NDC
72888-144
11-digit product format
728880144
Labeler code
72888
Product ID
72888-144_4859d9c4-bb8c-477b-e063-6294a90a7cb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DESVENLAFAXINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Advagen Pharma Ltd
Application
ANDA204028
Marketing category
ANDA
Marketing start
2022-01-31
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DESVENLAFAXINE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESVENLAFAXINE SUCCINATE100 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
72888-144-00DESVENLAFAXINE1000 in 1 PACKAGETABLET, EXTENDED RELEASE10006
72888-144-05DESVENLAFAXINE500 in 1 PACKAGETABLET, EXTENDED RELEASE5006
72888-144-30DESVENLAFAXINE30 in 1 PACKAGETABLET, EXTENDED RELEASE306
72888-144-90DESVENLAFAXINE90 in 1 PACKAGETABLET, EXTENDED RELEASE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-144-30EA - Each72888-1447a964803-acb2-4289-935e-50ec11d4b4e612023-07-06
72888-144-90EA - Each72888-1440678e804-a407-4455-9e20-09346dfe1d1a12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-144DESVENLAFAXINE TABLET, EXTENDED RELEASE [ADVAGEN PHARMA LTD]5Current NDC, 4 package rows20231220_ff837eb1-24c3-4c63-9b4b-c6b5935a9b47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSNff837eb1-24c3-4c63-9b4b-c6b5935a9b476
1607617desvenlafaxine succinate 25 MG 24HR Extended Release Oral TabletPSNff837eb1-24c3-4c63-9b4b-c6b5935a9b476
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSNff837eb1-24c3-4c63-9b4b-c6b5935a9b476
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCDff837eb1-24c3-4c63-9b4b-c6b5935a9b476
160761724 HR desvenlafaxine succinate 25 MG Extended Release Oral TabletSCDff837eb1-24c3-4c63-9b4b-c6b5935a9b476
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCDff837eb1-24c3-4c63-9b4b-c6b5935a9b476
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSYff837eb1-24c3-4c63-9b4b-c6b5935a9b476
1607617desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral TabletSYff837eb1-24c3-4c63-9b4b-c6b5935a9b476
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSYff837eb1-24c3-4c63-9b4b-c6b5935a9b476
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSN643bfe62-7885-4db4-9fff-5d8552b53d142
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCD643bfe62-7885-4db4-9fff-5d8552b53d142
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSY643bfe62-7885-4db4-9fff-5d8552b53d142

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72888-144-00728880144001000 TABLET, EXTENDED RELEASE in 1 PACKAGE (72888-144-00) 2022-01-31NoNoCurrent
72888-144-0572888014405500 TABLET, EXTENDED RELEASE in 1 PACKAGE (72888-144-05) 2022-01-31NoNoCurrent
72888-144-307288801443030 TABLET, EXTENDED RELEASE in 1 PACKAGE (72888-144-30) 2022-01-31NoNoCurrent
72888-144-907288801449090 TABLET, EXTENDED RELEASE in 1 PACKAGE (72888-144-90) 2022-01-31NoNoCurrent