FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
71335-1700
11-digit product format
713351700
Labeler code
71335
Product ID
71335-1700_4a9487ae-3632-40da-b2a7-238060205a74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204082
Marketing category
ANDA
Marketing start
2017-03-01
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
71335-1700-1Desvenlafaxine30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE305
71335-1700-2Desvenlafaxine28 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE285
71335-1700-3Desvenlafaxine60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE605
71335-1700-4Desvenlafaxine90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE905
71335-1700-5Desvenlafaxine180 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1805

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1700-1EA - Each71335-17002f5ec06d-ccde-45fb-a32d-6398b67ef40412024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1700DESVENLAFAXINE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 5 package rows20250223_aca478a7-eff6-4cd5-93a8-2dca69883a4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSNaca478a7-eff6-4cd5-93a8-2dca69883a4b5
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCDaca478a7-eff6-4cd5-93a8-2dca69883a4b5
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSYaca478a7-eff6-4cd5-93a8-2dca69883a4b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1700-17133517000130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1700-1) 2020-09-030000-00-00NoNoCurrent
71335-1700-27133517000228 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1700-2) 2025-01-300000-00-00NoNoCurrent
71335-1700-37133517000360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1700-3) 2025-01-300000-00-00NoNoCurrent
71335-1700-47133517000490 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1700-4) 2023-09-250000-00-00NoNoCurrent
71335-1700-571335170005180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1700-5) 2025-01-30NoNoHistorical