FDA.reportPublic FDA data

Pristiq

Product NDC
0008-1222
11-digit product format
000081222
Labeler code
0008
Product ID
0008-1222_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
2008-05-01
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
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 SUCCINATE100 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0008-1222-012024-01-30C16284748780-11030e365-39d1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PRISTIQ safely and effectively. See full prescribing information for PRISTIQ. PRISTIQ ® (desvenlafaxine) Extended-Release Tablets, for oral use Initial U.S. Approval: 2008
0008-1222-012024-01-30C16284748780-11030e365-39d1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PRISTIQ safely and effectively. See full prescribing information for PRISTIQ. PRISTIQ ® (desvenlafaxine) Extended-Release Tablets, for oral use Initial U.S. Approval: 2008
0008-1222-012024-01-30C16284748780-11030e365-39d1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PRISTIQ safely and effectively. See full prescribing information for PRISTIQ. PRISTIQ ® (desvenlafaxine) Extended-Release Tablets, for oral use Initial U.S. Approval: 2008
0008-1222-012024-01-30C16284748780-11030e365-39d1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PRISTIQ safely and effectively. See full prescribing information for PRISTIQ. PRISTIQ ® (desvenlafaxine) Extended-Release Tablets, for oral use Initial U.S. Approval: 2008
0008-1222-142024-01-30C16284748780-11030e365-39d1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PRISTIQ safely and effectively. See full prescribing information for PRISTIQ. PRISTIQ ® (desvenlafaxine) Extended-Release Tablets, for oral use Initial U.S. Approval: 2008
0008-1222-142024-01-30C16284748780-11030e365-39d1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PRISTIQ safely and effectively. See full prescribing information for PRISTIQ. PRISTIQ ® (desvenlafaxine) Extended-Release Tablets, for oral use Initial U.S. Approval: 2008
0008-1222-142024-01-30C16284748780-11030e365-39d1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PRISTIQ safely and effectively. See full prescribing information for PRISTIQ. PRISTIQ ® (desvenlafaxine) Extended-Release Tablets, for oral use Initial U.S. Approval: 2008
0008-1222-142024-01-30C16284748780-11030e365-39d1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PRISTIQ safely and effectively. See full prescribing information for PRISTIQ. PRISTIQ ® (desvenlafaxine) Extended-Release Tablets, for oral use Initial U.S. Approval: 2008
0008-1222-302024-01-30C16284748780-11030e365-39d1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PRISTIQ safely and effectively. See full prescribing information for PRISTIQ. PRISTIQ ® (desvenlafaxine) Extended-Release Tablets, for oral use Initial U.S. Approval: 2008
0008-1222-302024-01-30C16284748780-11030e365-39d1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PRISTIQ safely and effectively. See full prescribing information for PRISTIQ. PRISTIQ ® (desvenlafaxine) Extended-Release Tablets, for oral use Initial U.S. Approval: 2008
0008-1222-302024-01-30C16284748780-11030e365-39d1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PRISTIQ safely and effectively. See full prescribing information for PRISTIQ. PRISTIQ ® (desvenlafaxine) Extended-Release Tablets, for oral use Initial U.S. Approval: 2008
0008-1222-302024-01-30C16284748780-11030e365-39d1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PRISTIQ safely and effectively. See full prescribing information for PRISTIQ. PRISTIQ ® (desvenlafaxine) Extended-Release Tablets, for oral use Initial U.S. Approval: 2008
0008-1222-502024-01-30C16284748780-11030e365-39d1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PRISTIQ safely and effectively. See full prescribing information for PRISTIQ. PRISTIQ ® (desvenlafaxine) Extended-Release Tablets, for oral use Initial U.S. Approval: 2008
0008-1222-502024-01-30C16284748780-11030e365-39d1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PRISTIQ safely and effectively. See full prescribing information for PRISTIQ. PRISTIQ ® (desvenlafaxine) Extended-Release Tablets, for oral use Initial U.S. Approval: 2008
0008-1222-502024-01-30C16284748780-11030e365-39d1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PRISTIQ safely and effectively. See full prescribing information for PRISTIQ. PRISTIQ ® (desvenlafaxine) Extended-Release Tablets, for oral use Initial U.S. Approval: 2008
0008-1222-502024-01-30C16284748780-11030e365-39d1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PRISTIQ safely and effectively. See full prescribing information for PRISTIQ. PRISTIQ ® (desvenlafaxine) Extended-Release Tablets, for oral use Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0008-1222-01PristiqExtended-Release90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE9067
0008-1222-14PristiqExtended-Release14 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1467
0008-1222-30PristiqExtended-Release30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE3067
0008-1222-50PristiqExtended-Release1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE167
0008-1222-50PristiqExtended-Release100 in 1 CARTONTABLET, EXTENDED RELEASE10067

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0008-1222-01EA - Each0008-1222c9d8d2a5-3642-407a-80c8-c352f3b18d3612012-07-24
0008-1222-14EA - Each0008-12221790e36c-a419-4b8f-89ce-06cd556b539c12012-07-24
0008-1222-30EA - Each0008-12225a65b68d-75ba-4012-a224-75620cf23cd512012-07-24
0008-1222-50EA - Each0008-1222343e843e-305f-43ef-9a1a-b8d1ce236d1712012-07-24

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
0008-1222PRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]64Current NDC, Legacy NDC, 5 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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0008-1222-010000812220190 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1222-01) 2008-05-010000-00-00NoNoCurrent
0008-1222-140000812221414 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1222-14) 2008-05-010000-00-00NoNoCurrent
0008-1222-300000812223030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1222-30) 2008-05-010000-00-00NoNoCurrent
0008-1222-5000008122250100 BLISTER PACK in 1 CARTON (0008-1222-50) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK100 blister pack2008-05-010000-00-00NoNoCurrent