FDA.reportPublic FDA data

Pristiq

Product NDC
0008-1210
11-digit product format
000081210
Labeler code
0008
Product ID
0008-1210_b9acfefd-10c0-4942-9446-18bb456efb68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
desvenlafaxine succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Application
NDA021992
Marketing category
NDA
Marketing start
2015-04-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pristiq
Brand name suffix
Extended-Release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESVENLAFAXINE SUCCINATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZB22ENF0XR
Rxcui790267, 790290, 1607617, 1607619, 1874553, 1874559

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a9aae381-3b13-08a9-c49d-484a2c2a6dc8Product name720251106
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
99b326f2-4886-9fc8-8686-faef7b7f27ddProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0008-1210-30PristiqExtended-Release30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE3067

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0008-1210-30EA - Each0008-1210bd82481c-da57-495e-ad89-1babfa14a2db12015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DESVENLAFAXINE SUCCINATEACTIVE INGREDIENTZB22ENF0XRPRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]47
DESVENLAFAXINEACTIVE MOIETYNG99554ANWPRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]47
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]47
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]47
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]47
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]47
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2PRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]47
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]47
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]47
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990PRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]47
TALCINACTIVE INGREDIENT7SEV7J4R1UPRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]47
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]47

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0008-1210PRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]64Current NDC, Legacy NDC, 1 package rows20241219_0f43610c-f290-46ea-d186-4f998ed99fce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSN0f43610c-f290-46ea-d186-4f998ed99fce67
1607617desvenlafaxine succinate 25 MG 24HR Extended Release Oral TabletPSN0f43610c-f290-46ea-d186-4f998ed99fce67
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN0f43610c-f290-46ea-d186-4f998ed99fce67
790267Pristiq 100 MG 24HR Extended Release Oral TabletPSN0f43610c-f290-46ea-d186-4f998ed99fce67
1607619Pristiq 25 MG 24HR Extended Release Oral TabletPSN0f43610c-f290-46ea-d186-4f998ed99fce67
790290Pristiq 50 MG 24HR Extended Release Oral TabletPSN0f43610c-f290-46ea-d186-4f998ed99fce67
79026724 HR desvenlafaxine succinate 100 MG Extended Release Oral Tablet [Pristiq]SBD0f43610c-f290-46ea-d186-4f998ed99fce67
160761924 HR desvenlafaxine succinate 25 MG Extended Release Oral Tablet [Pristiq]SBD0f43610c-f290-46ea-d186-4f998ed99fce67
79029024 HR desvenlafaxine succinate 50 MG Extended Release Oral Tablet [Pristiq]SBD0f43610c-f290-46ea-d186-4f998ed99fce67
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCD0f43610c-f290-46ea-d186-4f998ed99fce67
160761724 HR desvenlafaxine succinate 25 MG Extended Release Oral TabletSCD0f43610c-f290-46ea-d186-4f998ed99fce67
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD0f43610c-f290-46ea-d186-4f998ed99fce67
79026724 HR Pristiq 100 MG Extended Release Oral TabletSY0f43610c-f290-46ea-d186-4f998ed99fce67
160761924 HR Pristiq 25 MG Extended Release Oral TabletSY0f43610c-f290-46ea-d186-4f998ed99fce67
79029024 HR Pristiq 50 MG Extended Release Oral TabletSY0f43610c-f290-46ea-d186-4f998ed99fce67
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSY0f43610c-f290-46ea-d186-4f998ed99fce67
1607617desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral TabletSY0f43610c-f290-46ea-d186-4f998ed99fce67
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY0f43610c-f290-46ea-d186-4f998ed99fce67
790267Pristiq 100 MG (as desvenlafaxine succinate 152 MG) 24 HR Extended Release Oral TabletSY0f43610c-f290-46ea-d186-4f998ed99fce67
1607619Pristiq 25 MG (as desvenlafaxine succinate 38 MG) 24 HR Extended Release Oral TabletSY0f43610c-f290-46ea-d186-4f998ed99fce67
790290Pristiq 50 MG (as desvenlafaxine succinate 76 MG) 24 HR Extended Release Oral TabletSY0f43610c-f290-46ea-d186-4f998ed99fce67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0008-1210-300000812103030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1210-30) 2015-04-010000-00-00NoNoCurrent