FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
10135-821
11-digit product format
101350821
Labeler code
10135
Product ID
10135-821_387ce260-7ac6-36e8-e063-6394a90a4e49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Marlex Pharmaceuticals, Inc.
Application
ANDA204805
Marketing category
ANDA
Marketing start
2025-07-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Desvenlafaxine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESVENLAFAXINE SUCCINATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZB22ENF0XR
Rxcui1874553, 1874559

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
10135-821-10Desvenlafaxine1000 in 1 BOTTLETABLET, EXTENDED RELEASE10001
10135-821-14Desvenlafaxine14 in 1 BOTTLETABLET, EXTENDED RELEASE141
10135-821-30Desvenlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE301
10135-821-90Desvenlafaxine90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-821-30EA - Each10135-821df442f01-fd03-47d8-9a7a-a7920f9752e412025-09-12
10135-821-90EA - Each10135-821f8da7a29-9448-441b-bce8-a50a052701a712025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSN387cea91-6924-2a68-e063-6394a90a8f751
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN387cea91-6924-2a68-e063-6394a90a8f751
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCD387cea91-6924-2a68-e063-6394a90a8f751
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD387cea91-6924-2a68-e063-6394a90a8f751
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSY387cea91-6924-2a68-e063-6394a90a8f751
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY387cea91-6924-2a68-e063-6394a90a8f751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
10135-821-10101350821101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-10) 2025-07-01NoNoHistorical
10135-821-141013508211414 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-14) 2025-07-01NoNoHistorical
10135-821-301013508213030 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-30) 2025-07-01NoNoHistorical
10135-821-901013508219090 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-90) 2025-07-01NoNoHistorical