FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
71335-1975
11-digit product format
713351975
Labeler code
71335
Product ID
71335-1975_cf4737cf-9ea4-449e-b9c5-9175ebd61f0f
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
2021-01-05
Substance
DESVENLAFAXINE SUCCINATE
Active strength
25 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 SUCCINATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZB22ENF0XR
Rxcui1607617

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a9aae381-3b13-08a9-c49d-484a2c2a6dc8Product name720251106
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
99b326f2-4886-9fc8-8686-faef7b7f27ddProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1975-1Desvenlafaxine30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE30107
71335-1975-2Desvenlafaxine60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE60107
71335-1975-3Desvenlafaxine90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE90107
71335-1975-4Desvenlafaxine120 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE120107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1975-2EA - Each71335-1975f9a288a5-1801-4d7f-a377-686be1089bc512023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1975DESVENLAFAXINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 4 package rows20240726_1d8889c9-9403-4b4b-8abd-7dc9a9fc1816.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1607617desvenlafaxine succinate 25 MG 24HR Extended Release Oral TabletPSN1d8889c9-9403-4b4b-8abd-7dc9a9fc1816107
160761724 HR desvenlafaxine succinate 25 MG Extended Release Oral TabletSCD1d8889c9-9403-4b4b-8abd-7dc9a9fc1816107
1607617desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral TabletSY1d8889c9-9403-4b4b-8abd-7dc9a9fc1816107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1975-17133519750130 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-1975-1) 2021-10-140000-00-00NoNoCurrent
71335-1975-27133519750260 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-1975-2) 2024-07-180000-00-00NoNoCurrent
71335-1975-37133519750390 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-1975-3) 2024-07-180000-00-00NoNoCurrent
71335-1975-471335197504120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-1975-4) 2021-10-140000-00-00NoNoCurrent