FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
68788-7194
11-digit product format
687887194
Labeler code
68788
Product ID
68788-7194_a6d606dc-0f00-487f-8772-cd2d5f2efe7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceutical, Inc.
Application
ANDA204003
Marketing category
ANDA
Marketing start
2018-07-18
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
68788-7194-1Desvenlafaxine100 in 1 BOTTLETABLET, EXTENDED RELEASE1009
68788-7194-3Desvenlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE309
68788-7194-6Desvenlafaxine60 in 1 BOTTLETABLET, EXTENDED RELEASE609
68788-7194-9Desvenlafaxine90 in 1 BOTTLETABLET, EXTENDED RELEASE909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7194-1EA - Each68788-71944f0cfdef-1bc8-4f00-8aea-87393dc3b32612018-09-05
68788-7194-3EA - Each68788-7194e7665b48-2640-4950-844d-440cf5a66ac112018-09-05
68788-7194-6EA - Each68788-719438cccbb1-4488-45cd-90ff-47ff800e91da12018-09-05
68788-7194-9EA - Each68788-71946768e727-f2a1-450e-93d2-8a862eeafc6b12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7194DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICAL, INC.]8Current NDC, Legacy NDC, 4 package rows20250315_4b786ea1-309d-440c-b091-38d6b1f7fbd3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN4b786ea1-309d-440c-b091-38d6b1f7fbd39
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD4b786ea1-309d-440c-b091-38d6b1f7fbd39
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY4b786ea1-309d-440c-b091-38d6b1f7fbd39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7194-168788719401100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7194-1) 2018-07-180000-00-00NoNoCurrent
68788-7194-36878871940330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7194-3) 2018-07-180000-00-00NoNoCurrent
68788-7194-66878871940660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7194-6) 2018-07-180000-00-00NoNoCurrent
68788-7194-96878871940990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7194-9) 2018-07-180000-00-00NoNoCurrent