Desvenlafaxine Succinate

Product NDC
71335-1331
11-digit product format
713351331
Labeler code
71335
Product ID
71335-1331_56c9e8ee-1460-4a4c-8033-65d9afb358c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine Succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204172
Marketing category
ANDA
Marketing start
2017-03-01
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESVENLAFAXINE SUCCINATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZB22ENF0XR

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a9aae381-3b13-08a9-c49d-484a2c2a6dc8Product name720251106
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
99b326f2-4886-9fc8-8686-faef7b7f27ddProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1331-12024-05-20C16284748780-11030e365-108a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
71335-1331-12024-05-20C16284748780-11030e365-108a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
71335-1331-22024-05-20C16284748780-11030e365-108a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
71335-1331-22024-05-20C16284748780-11030e365-108a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
71335-1331-32024-05-20C16284748780-11030e365-108a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
71335-1331-32024-05-20C16284748780-11030e365-108a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
71335-1331-42024-05-20C16284748780-11030e365-108a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
71335-1331-42024-05-20C16284748780-11030e365-108a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
71335-1331-12024-01-30C16284748780-11030e365-108a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
71335-1331-12024-01-30C16284748780-11030e365-108a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
71335-1331-22024-01-30C16284748780-11030e365-108a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
71335-1331-22024-01-30C16284748780-11030e365-108a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
71335-1331-32024-01-30C16284748780-11030e365-108a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
71335-1331-32024-01-30C16284748780-11030e365-108a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
71335-1331-42024-01-30C16284748780-11030e365-108a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
71335-1331-42024-01-30C16284748780-11030e365-108a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1331-1Desvenlafaxine Succinate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE30101
71335-1331-2Desvenlafaxine Succinate28 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE28101
71335-1331-3Desvenlafaxine Succinate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE90101
71335-1331-4Desvenlafaxine Succinate60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE60101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1331DESVENLAFAXINE SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 4 package rows20240522_56c9e8ee-1460-4a4c-8033-65d9afb358c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSN56c9e8ee-1460-4a4c-8033-65d9afb358c8101
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCD56c9e8ee-1460-4a4c-8033-65d9afb358c8101
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSY56c9e8ee-1460-4a4c-8033-65d9afb358c8101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1331-17133513310130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1331-1) 2019-09-030000-00-00NoNoCurrent
71335-1331-27133513310228 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1331-2) 2024-05-200000-00-00NoNoCurrent
71335-1331-37133513310390 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1331-3) 2024-05-200000-00-00NoNoCurrent
71335-1331-47133513310460 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1331-4) 2024-05-200000-00-00NoNoCurrent