FDA.reportPublic FDA data

DESVENLAFAXINE

Product NDC
71335-2512
11-digit product format
713352512
Labeler code
71335
Product ID
71335-2512_a87becdb-b5d0-4c1f-8016-07c64969e3b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DESVENLAFAXINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204028
Marketing category
ANDA
Marketing start
2022-01-31
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
99b326f2-4886-9fc8-8686-faef7b7f27ddProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2512-1DESVENLAFAXINE30 in 1 BOTTLETABLET, EXTENDED RELEASE302
71335-2512-2DESVENLAFAXINE28 in 1 BOTTLETABLET, EXTENDED RELEASE282
71335-2512-3DESVENLAFAXINE90 in 1 BOTTLETABLET, EXTENDED RELEASE902
71335-2512-4DESVENLAFAXINE60 in 1 BOTTLETABLET, EXTENDED RELEASE602

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSN643bfe62-7885-4db4-9fff-5d8552b53d142
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCD643bfe62-7885-4db4-9fff-5d8552b53d142
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSY643bfe62-7885-4db4-9fff-5d8552b53d142

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2512-17133525120130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2512-1) 2025-06-04NoNoCurrent
71335-2512-27133525120228 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2512-2) 2025-06-04NoNoCurrent
71335-2512-37133525120390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2512-3) 2025-06-04NoNoCurrent
71335-2512-47133525120460 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2512-4) 2025-06-04NoNoCurrent