FDA.reportPublic FDA data

DESVENLAFAXINE

Product NDC
68788-8760
11-digit product format
687888760
Labeler code
68788
Product ID
68788-8760_337771e1-3a8c-47e1-9c09-4df4abfaef3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DESVENLAFAXINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA204028
Marketing category
ANDA
Marketing start
2024-11-11
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
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
68788-8760-1DESVENLAFAXINE100 in 1 PACKAGETABLET, EXTENDED RELEASE1002
68788-8760-3DESVENLAFAXINE30 in 1 PACKAGETABLET, EXTENDED RELEASE302
68788-8760-6DESVENLAFAXINE60 in 1 PACKAGETABLET, EXTENDED RELEASE602
68788-8760-9DESVENLAFAXINE90 in 1 PACKAGETABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8760-1EA - Each68788-8760a9ecaec6-075b-4eb2-b9e1-5d3911eaa94012025-02-10
68788-8760-3EA - Each68788-87606ef67868-be30-4714-b0a7-dd391a8d477b12025-02-10
68788-8760-6EA - Each68788-876071f12376-deb4-4a9c-85fe-c371fa784af412025-02-10
68788-8760-9EA - Each68788-87605cd39e38-9618-412e-b19a-9f5bd00c8ec812025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8760DESVENLAFAXINE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 4 package rows20241113_5a136b61-f734-43d5-86fc-059ff3b5342a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN5a136b61-f734-43d5-86fc-059ff3b5342a2
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD5a136b61-f734-43d5-86fc-059ff3b5342a2
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY5a136b61-f734-43d5-86fc-059ff3b5342a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8760-168788876001100 TABLET, EXTENDED RELEASE in 1 PACKAGE (68788-8760-1) 2024-11-11NoNoHistorical
68788-8760-36878887600330 TABLET, EXTENDED RELEASE in 1 PACKAGE (68788-8760-3) 2024-11-11NoNoHistorical
68788-8760-66878887600660 TABLET, EXTENDED RELEASE in 1 PACKAGE (68788-8760-6) 2024-11-11NoNoHistorical
68788-8760-96878887600990 TABLET, EXTENDED RELEASE in 1 PACKAGE (68788-8760-9) 2024-11-11NoNoHistorical