FDA.reportPublic FDA data

DESVENLAFAXINE

Product NDC
72888-143
11-digit product format
728880143
Labeler code
72888
Product ID
72888-143_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
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESVENLAFAXINE SUCCINATE50 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
99b326f2-4886-9fc8-8686-faef7b7f27ddProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72888-143-00DESVENLAFAXINE1000 in 1 PACKAGETABLET, EXTENDED RELEASE10006
72888-143-05DESVENLAFAXINE500 in 1 PACKAGETABLET, EXTENDED RELEASE5006
72888-143-30DESVENLAFAXINE30 in 1 PACKAGETABLET, EXTENDED RELEASE306
72888-143-90DESVENLAFAXINE90 in 1 PACKAGETABLET, EXTENDED RELEASE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-143-05EA - Each72888-1439101a06e-8e65-4d37-9d77-60ca0c6ebbbe12025-06-13
72888-143-30EA - Each72888-143b30c1f98-2996-4ed0-97eb-0aca8980de1512023-07-06
72888-143-90EA - Each72888-143bb921166-ed88-4103-8400-3c8a36f7a25e12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-143DESVENLAFAXINE 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
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN48d3a09e-850d-472d-8fb2-996a5167b16d7
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD48d3a09e-850d-472d-8fb2-996a5167b16d7
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY48d3a09e-850d-472d-8fb2-996a5167b16d7
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
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN1d86d1dc-d685-43aa-e063-6294a90a99073
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD1d86d1dc-d685-43aa-e063-6294a90a99073
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY1d86d1dc-d685-43aa-e063-6294a90a99073
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN5a136b61-f734-43d5-86fc-059ff3b5342a2
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN2dce1542-ead5-1b24-e063-6294a90a6df02
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD5a136b61-f734-43d5-86fc-059ff3b5342a2
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD2dce1542-ead5-1b24-e063-6294a90a6df02
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY5a136b61-f734-43d5-86fc-059ff3b5342a2
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY2dce1542-ead5-1b24-e063-6294a90a6df02
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN5b6e86bc-24a3-4f8c-aff7-6e1e17a7d1a41
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD5b6e86bc-24a3-4f8c-aff7-6e1e17a7d1a41
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY5b6e86bc-24a3-4f8c-aff7-6e1e17a7d1a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72888-143-00728880143001000 TABLET, EXTENDED RELEASE in 1 PACKAGE (72888-143-00) 2022-01-31NoNoCurrent
72888-143-0572888014305500 TABLET, EXTENDED RELEASE in 1 PACKAGE (72888-143-05) 2022-01-31NoNoCurrent
72888-143-307288801433030 TABLET, EXTENDED RELEASE in 1 PACKAGE (72888-143-30) 2022-01-31NoNoCurrent
72888-143-907288801439090 TABLET, EXTENDED RELEASE in 1 PACKAGE (72888-143-90) 2022-01-31NoNoCurrent