FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
68788-7175
11-digit product format
687887175
Labeler code
68788
Product ID
68788-7175_59b42830-3574-450c-9d7b-53e2834c59db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA204003
Marketing category
ANDA
Marketing start
2018-06-11
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
Rxcui1874553

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
68788-7175-1Desvenlafaxine100 in 1 BOTTLETABLET, EXTENDED RELEASE10010
68788-7175-3Desvenlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE3010
68788-7175-6Desvenlafaxine60 in 1 BOTTLETABLET, EXTENDED RELEASE6010
68788-7175-9Desvenlafaxine90 in 1 BOTTLETABLET, EXTENDED RELEASE9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7175-1EA - Each68788-7175a284d7d4-33e9-46c7-9096-fa5c1b73c5d312018-09-05
68788-7175-3EA - Each68788-717568f59f5b-df48-424c-b2e1-a8a74c1b923812018-09-05
68788-7175-6EA - Each68788-717588b8b0e3-5ce4-4d2a-8432-ebad2c748ee812018-09-05
68788-7175-9EA - Each68788-71756fe13f03-b62f-4a9e-b0ed-ff9427a2bb6c12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7175DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 4 package rows20250315_b4a5efab-3765-4ea5-a8cd-66e67e76c845.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSNb4a5efab-3765-4ea5-a8cd-66e67e76c84510
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCDb4a5efab-3765-4ea5-a8cd-66e67e76c84510
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSYb4a5efab-3765-4ea5-a8cd-66e67e76c84510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7175-168788717501100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7175-1) 2018-06-110000-00-00NoNoCurrent
68788-7175-36878871750330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7175-3) 2018-06-110000-00-00NoNoCurrent
68788-7175-66878871750660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7175-6) 2018-06-110000-00-00NoNoCurrent
68788-7175-96878871750990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7175-9) 2018-06-110000-00-00NoNoCurrent