FDA.reportPublic FDA data

Desvenlafaxine Succinate

Product NDC
33342-389
11-digit product format
333420389
Labeler code
33342
Product ID
33342-389_edf18b33-a226-44f8-9f42-c409e691ee64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA211427
Marketing category
ANDA
Marketing start
2018-06-16
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESVENLAFAXINE SUCCINATE100 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
33342-389-07Desvenlafaxine Succinate30 in 1 BOTTLETABLET, EXTENDED RELEASE301
33342-389-10Desvenlafaxine Succinate90 in 1 BOTTLETABLET, EXTENDED RELEASE901
33342-389-12Desvenlafaxine Succinate10 in 1 CARTONTABLET, EXTENDED RELEASE101
33342-389-12Desvenlafaxine Succinate10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-389DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE [MACLEODS PHARMACEUTICALS LIMITED]1Current NDC, 4 package rows20250412_edf18b33-a226-44f8-9f42-c409e691ee64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSNedf18b33-a226-44f8-9f42-c409e691ee641
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSNedf18b33-a226-44f8-9f42-c409e691ee641
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCDedf18b33-a226-44f8-9f42-c409e691ee641
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCDedf18b33-a226-44f8-9f42-c409e691ee641
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSYedf18b33-a226-44f8-9f42-c409e691ee641
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSYedf18b33-a226-44f8-9f42-c409e691ee641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-389-073334203890730 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-389-07) 2018-06-16NoNoCurrent
33342-389-103334203891090 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-389-10) 2018-06-16NoNoCurrent
33342-389-123334203891210 BLISTER PACK in 1 CARTON (33342-389-12) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2018-06-16NoNoCurrent