FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
63304-191
11-digit product format
633040191
Labeler code
63304
Product ID
63304-191_cd04a0b2-a7f2-4629-997f-af2a8e65f15b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA204150
Marketing category
NDA
Marketing start
2013-03-05
Substance
DESVENLAFAXINE
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
DESVENLAFAXINE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNG99554ANW
Rxcui790264, 790288

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
63304-191-30Desvenlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE3034
63304-191-90Desvenlafaxine90 in 1 BOTTLETABLET, EXTENDED RELEASE9034

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-191-30EA - Each63304-19187a40623-90aa-4ad3-9bd1-eff2ef3fb31712013-05-02
63304-191-90EA - Each63304-191f4ba549b-15bc-4dfb-bf3e-bece26743b7812013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DESVENLAFAXINEACTIVE INGREDIENTNG99554ANWDESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]10
DESVENLAFAXINEACTIVE MOIETYNG99554ANWDESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]10
ALGINIC ACIDINACTIVE INGREDIENT8C3Z4148WZDESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]10
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]10
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEDESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]10
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BDESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]10
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]10
TALCINACTIVE INGREDIENT7SEV7J4R1UDESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-191DESVENLAFAXINE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]34Current NDC, Legacy NDC, 2 package rows20230830_91cf39c9-4d26-480a-a3a3-a3d8d4c4d222.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
790264desvenlafaxine 100 MG 24HR Extended Release Oral TabletPSN91cf39c9-4d26-480a-a3a3-a3d8d4c4d22234
790288desvenlafaxine 50 MG 24HR Extended Release Oral TabletPSN91cf39c9-4d26-480a-a3a3-a3d8d4c4d22234
79026424 HR desvenlafaxine 100 MG Extended Release Oral TabletSCD91cf39c9-4d26-480a-a3a3-a3d8d4c4d22234
79028824 HR desvenlafaxine 50 MG Extended Release Oral TabletSCD91cf39c9-4d26-480a-a3a3-a3d8d4c4d22234
790264desvenlafaxine 100 MG 24 HR Extended Release Oral TabletSY91cf39c9-4d26-480a-a3a3-a3d8d4c4d22234
790288desvenlafaxine 50 MG 24 HR Extended Release Oral TabletSY91cf39c9-4d26-480a-a3a3-a3d8d4c4d22234

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63304-191-306330401913030 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-191-30) 2013-03-050000-00-00NoNoCurrent
63304-191-906330401919090 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-191-90) 2013-03-050000-00-00NoNoCurrent