FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
71335-1815
11-digit product format
713351815
Labeler code
71335
Product ID
71335-1815_7872f7a6-43f9-4ec4-9cc1-0bf90af847ed
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
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
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
71335-1815-1Desvenlafaxine30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE30106
71335-1815-2Desvenlafaxine28 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE28106
71335-1815-3Desvenlafaxine90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE90106
71335-1815-4Desvenlafaxine60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE60106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1815DESVENLAFAXINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 4 package rows20240726_6741bdef-dc58-47be-b28d-c43476dc8bde.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSN6741bdef-dc58-47be-b28d-c43476dc8bde106
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCD6741bdef-dc58-47be-b28d-c43476dc8bde106
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSY6741bdef-dc58-47be-b28d-c43476dc8bde106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1815-17133518150130 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-1815-1) 2024-07-170000-00-00NoNoCurrent
71335-1815-27133518150228 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-1815-2) 2021-03-190000-00-00NoNoCurrent
71335-1815-37133518150390 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-1815-3) 2024-07-170000-00-00NoNoCurrent
71335-1815-47133518150460 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-1815-4) 2024-06-060000-00-00NoNoCurrent