FDA.reportPublic FDA data

DESVENLAFAXINE

Product NDC
71335-2575
11-digit product format
713352575
Labeler code
71335
Product ID
71335-2575_c69838a2-6378-4bb4-9109-607fe77550cb
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
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
Rxcui1874559

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
71335-2575-1DESVENLAFAXINE30 in 1 PACKAGETABLET, EXTENDED RELEASE301
71335-2575-2DESVENLAFAXINE28 in 1 PACKAGETABLET, EXTENDED RELEASE281
71335-2575-3DESVENLAFAXINE60 in 1 PACKAGETABLET, EXTENDED RELEASE601
71335-2575-4DESVENLAFAXINE90 in 1 PACKAGETABLET, EXTENDED RELEASE901
71335-2575-5DESVENLAFAXINE180 in 1 PACKAGETABLET, EXTENDED RELEASE1801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2575DESVENLAFAXINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1Current NDC, 5 package rows20250207_5b6e86bc-24a3-4f8c-aff7-6e1e17a7d1a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN5b6e86bc-24a3-4f8c-aff7-6e1e17a7d1a41
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD5b6e86bc-24a3-4f8c-aff7-6e1e17a7d1a41
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY5b6e86bc-24a3-4f8c-aff7-6e1e17a7d1a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2575-17133525750130 TABLET, EXTENDED RELEASE in 1 PACKAGE (71335-2575-1) 2025-02-05NoNoCurrent
71335-2575-27133525750228 TABLET, EXTENDED RELEASE in 1 PACKAGE (71335-2575-2) 2025-02-05NoNoCurrent
71335-2575-37133525750360 TABLET, EXTENDED RELEASE in 1 PACKAGE (71335-2575-3) 2025-02-05NoNoCurrent
71335-2575-47133525750490 TABLET, EXTENDED RELEASE in 1 PACKAGE (71335-2575-4) 2025-02-05NoNoCurrent
71335-2575-571335257505180 TABLET, EXTENDED RELEASE in 1 PACKAGE (71335-2575-5) 2025-02-05NoNoCurrent