FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
0591-4060
11-digit product format
005914060
Labeler code
0591
Product ID
0591-4060_9ae096b1-2fff-4410-b1c5-799171a05d54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA204065
Marketing category
ANDA
Marketing start
2017-03-01
Substance
DESVENLAFAXINE SUCCINATE
Active strength
25 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 SUCCINATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZB22ENF0XR
Rxcui1607617, 1874553, 1874559

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-4060-30Desvenlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE3027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-4060-30EA - Each0591-40600b806e67-41b2-489c-b765-49bb374b535412017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-4060DESVENLAFAXINE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]26Current NDC, Legacy NDC, 1 package rows20240524_617476f9-62d7-40ef-a1b1-c349d4ad706f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSN617476f9-62d7-40ef-a1b1-c349d4ad706f27
1607617desvenlafaxine succinate 25 MG 24HR Extended Release Oral TabletPSN617476f9-62d7-40ef-a1b1-c349d4ad706f27
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN617476f9-62d7-40ef-a1b1-c349d4ad706f27
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCD617476f9-62d7-40ef-a1b1-c349d4ad706f27
160761724 HR desvenlafaxine succinate 25 MG Extended Release Oral TabletSCD617476f9-62d7-40ef-a1b1-c349d4ad706f27
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD617476f9-62d7-40ef-a1b1-c349d4ad706f27
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSY617476f9-62d7-40ef-a1b1-c349d4ad706f27
1607617desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral TabletSY617476f9-62d7-40ef-a1b1-c349d4ad706f27
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY617476f9-62d7-40ef-a1b1-c349d4ad706f27
1607617desvenlafaxine succinate 25 MG 24HR Extended Release Oral TabletPSNbbbb837b-7587-4870-870f-a5b14ade4e305
160761724 HR desvenlafaxine succinate 25 MG Extended Release Oral TabletSCDbbbb837b-7587-4870-870f-a5b14ade4e305
1607617desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral TabletSYbbbb837b-7587-4870-870f-a5b14ade4e305

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-4060-300059140603030 TABLET, EXTENDED RELEASE in 1 BOTTLE (0591-4060-30) 2017-03-010000-00-00NoNoCurrent