FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
71335-1753
11-digit product format
713351753
Labeler code
71335
Product ID
71335-1753_3dd007f9-261b-47e8-8dfc-d92ffdd2f430
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210014
Marketing category
ANDA
Marketing start
2020-08-01
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
99b326f2-4886-9fc8-8686-faef7b7f27ddProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1753-1Desvenlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE30106
71335-1753-2Desvenlafaxine28 in 1 BOTTLETABLET, EXTENDED RELEASE28106
71335-1753-3Desvenlafaxine60 in 1 BOTTLETABLET, EXTENDED RELEASE60106
71335-1753-4Desvenlafaxine90 in 1 BOTTLETABLET, EXTENDED RELEASE90106
71335-1753-5Desvenlafaxine180 in 1 BOTTLETABLET, EXTENDED RELEASE180106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1753DESVENLAFAXINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 5 package rows20240727_a6c2316d-2a51-4975-a061-dc72f2724b2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSNa6c2316d-2a51-4975-a061-dc72f2724b2f106
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCDa6c2316d-2a51-4975-a061-dc72f2724b2f106
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSYa6c2316d-2a51-4975-a061-dc72f2724b2f106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1753-17133517530130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1753-1) 2021-01-120000-00-00NoNoCurrent
71335-1753-27133517530228 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1753-2) 2024-07-170000-00-00NoNoCurrent
71335-1753-37133517530360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1753-3) 2024-07-170000-00-00NoNoCurrent
71335-1753-47133517530490 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1753-4) 2021-08-250000-00-00NoNoCurrent
71335-1753-571335175305180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1753-5) 2024-07-17NoNoCurrent