FDA.reportPublic FDA data

Effexor

Product NDC
0008-0833
11-digit product format
000080833
Labeler code
0008
Product ID
0008-0833_46df92d7-cc7b-4b8c-8f40-921dc6b4a5d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Application
NDA020699
Marketing category
NDA
Marketing start
1997-11-01
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
75 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
17db3736-056c-48b9-b0f4-00fccabb14e6Product name520251118
7be8b949-f2c0-bdd8-e89d-8af92c1b2eadProduct name920250224
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0008-0833-02EffexorXR1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE150
0008-0833-03EffexorXR100 in 1 CARTONCAPSULE, EXTENDED RELEASE10050
0008-0833-20EffexorXR15 in 1 BOTTLECAPSULE, EXTENDED RELEASE1550
0008-0833-21EffexorXR30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3050
0008-0833-22EffexorXR90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9050

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0008-0833-02EA - Each0008-08331a5d298c-2c72-4749-857c-94d1f378490812012-07-24
0008-0833-03EA - Each0008-083329b06970-e2e2-4715-891b-419a327fa5fa12012-07-24
0008-0833-20EA - Each0008-083337c8f82f-aa22-4e76-8c26-a0dbd280d52712012-07-24
0008-0833-21EA - Each0008-08334f2803f3-6fc3-448a-8b3d-723e704d32f612012-07-24
0008-0833-22EA - Each0008-0833a5dd65cc-08c0-4e8a-96a0-d8d9ca217cea12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOEFFEXOR XR (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]31
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGEFFEXOR XR (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]31
ETHYLCELLULOSE (100 MPA.S)INACTIVE INGREDIENT47MLB0F1MVEFFEXOR XR (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]31
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675EFFEXOR XR (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]31
GELATININACTIVE INGREDIENT2G86QN327LEFFEXOR XR (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]31
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6EFFEXOR XR (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]31
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEFFEXOR XR (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]31
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MEFFEXOR XR (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]31
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEFFEXOR XR (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]31
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOEFFEXOR XR (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGEFFEXOR XR (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
venlafaxine hydrochlorideACTIVE INGREDIENT7D7RX5A8MOEFFEXOR XR (VENLAFAXINE HYDROCHLORIDE ) CAPSULE, EXTENDED RELEASE EFFEXOR XR (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA]2
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGEFFEXOR XR (VENLAFAXINE HYDROCHLORIDE ) CAPSULE, EXTENDED RELEASE EFFEXOR XR (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [STAT RX USA]2
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOEFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGEFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
ETHYLCELLULOSE (100 MPA.S)INACTIVE INGREDIENT47MLB0F1MVEFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
GELATININACTIVE INGREDIENT2G86QN327LEFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6EFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MEFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEFFEXOR XR EXTENDED-RELEASE (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0008-0833EFFEXOR XR (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]49Legacy NDC, 5 package rows20241101_53c3e7ac-1852-4d70-d2b6-4fca819acf26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
729931Effexor XR 150 MG 24HR Extended Release Oral CapsulePSN53c3e7ac-1852-4d70-d2b6-4fca819acf2650
729932Effexor XR 37.5 MG 24HR Extended Release Oral CapsulePSN53c3e7ac-1852-4d70-d2b6-4fca819acf2650
729929Effexor XR 75 MG 24HR Extended Release Oral CapsulePSN53c3e7ac-1852-4d70-d2b6-4fca819acf2650
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN53c3e7ac-1852-4d70-d2b6-4fca819acf2650
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN53c3e7ac-1852-4d70-d2b6-4fca819acf2650
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN53c3e7ac-1852-4d70-d2b6-4fca819acf2650
72993124 HR venlafaxine 150 MG Extended Release Oral Capsule [Effexor]SBD53c3e7ac-1852-4d70-d2b6-4fca819acf2650
72993224 HR venlafaxine 37.5 MG Extended Release Oral Capsule [Effexor]SBD53c3e7ac-1852-4d70-d2b6-4fca819acf2650
72992924 HR venlafaxine 75 MG Extended Release Oral Capsule [Effexor]SBD53c3e7ac-1852-4d70-d2b6-4fca819acf2650
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD53c3e7ac-1852-4d70-d2b6-4fca819acf2650
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD53c3e7ac-1852-4d70-d2b6-4fca819acf2650
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD53c3e7ac-1852-4d70-d2b6-4fca819acf2650
72993124 HR Effexor 150 MG Extended Release Oral CapsuleSY53c3e7ac-1852-4d70-d2b6-4fca819acf2650
72993224 HR Effexor 37.5 MG Extended Release Oral CapsuleSY53c3e7ac-1852-4d70-d2b6-4fca819acf2650
72992924 HR Effexor 75 MG Extended Release Oral CapsuleSY53c3e7ac-1852-4d70-d2b6-4fca819acf2650
729931Effexor XR 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral CapsuleSY53c3e7ac-1852-4d70-d2b6-4fca819acf2650
729931Effexor XR 150 MG 24 HR Extended Release Oral CapsuleSY53c3e7ac-1852-4d70-d2b6-4fca819acf2650
729932Effexor XR 37.5 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral CapsuleSY53c3e7ac-1852-4d70-d2b6-4fca819acf2650
729932Effexor XR 37.5 MG 24 HR Extended Release Oral CapsuleSY53c3e7ac-1852-4d70-d2b6-4fca819acf2650
729929Effexor XR 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral CapsuleSY53c3e7ac-1852-4d70-d2b6-4fca819acf2650
729929Effexor XR 75 MG 24 HR Extended Release Oral CapsuleSY53c3e7ac-1852-4d70-d2b6-4fca819acf2650
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY53c3e7ac-1852-4d70-d2b6-4fca819acf2650
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY53c3e7ac-1852-4d70-d2b6-4fca819acf2650
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY53c3e7ac-1852-4d70-d2b6-4fca819acf2650
729931Effexor XR 150 MG 24HR Extended Release Oral CapsulePSNb379b413-5d66-4adb-8521-3978f10bbd1d4
729932Effexor XR 37.5 MG 24HR Extended Release Oral CapsulePSNb379b413-5d66-4adb-8521-3978f10bbd1d4
729929Effexor XR 75 MG 24HR Extended Release Oral CapsulePSNb379b413-5d66-4adb-8521-3978f10bbd1d4
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNb379b413-5d66-4adb-8521-3978f10bbd1d4
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNb379b413-5d66-4adb-8521-3978f10bbd1d4
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNb379b413-5d66-4adb-8521-3978f10bbd1d4
72993124 HR venlafaxine 150 MG Extended Release Oral Capsule [Effexor]SBDb379b413-5d66-4adb-8521-3978f10bbd1d4
72993224 HR venlafaxine 37.5 MG Extended Release Oral Capsule [Effexor]SBDb379b413-5d66-4adb-8521-3978f10bbd1d4
72992924 HR venlafaxine 75 MG Extended Release Oral Capsule [Effexor]SBDb379b413-5d66-4adb-8521-3978f10bbd1d4
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDb379b413-5d66-4adb-8521-3978f10bbd1d4
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDb379b413-5d66-4adb-8521-3978f10bbd1d4
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDb379b413-5d66-4adb-8521-3978f10bbd1d4
72993124 HR Effexor 150 MG Extended Release Oral CapsuleSYb379b413-5d66-4adb-8521-3978f10bbd1d4
72993224 HR Effexor 37.5 MG Extended Release Oral CapsuleSYb379b413-5d66-4adb-8521-3978f10bbd1d4
72992924 HR Effexor 75 MG Extended Release Oral CapsuleSYb379b413-5d66-4adb-8521-3978f10bbd1d4
729931Effexor XR 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral CapsuleSYb379b413-5d66-4adb-8521-3978f10bbd1d4
729931Effexor XR 150 MG 24 HR Extended Release Oral CapsuleSYb379b413-5d66-4adb-8521-3978f10bbd1d4
729932Effexor XR 37.5 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral CapsuleSYb379b413-5d66-4adb-8521-3978f10bbd1d4
729932Effexor XR 37.5 MG 24 HR Extended Release Oral CapsuleSYb379b413-5d66-4adb-8521-3978f10bbd1d4
729929Effexor XR 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral CapsuleSYb379b413-5d66-4adb-8521-3978f10bbd1d4
729929Effexor XR 75 MG 24 HR Extended Release Oral CapsuleSYb379b413-5d66-4adb-8521-3978f10bbd1d4
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYb379b413-5d66-4adb-8521-3978f10bbd1d4
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYb379b413-5d66-4adb-8521-3978f10bbd1d4
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYb379b413-5d66-4adb-8521-3978f10bbd1d4
729931Effexor XR 150 MG 24HR Extended Release Oral CapsulePSNf2f03495-12b6-457a-901f-958b9c844bfd2
729932Effexor XR 37.5 MG 24HR Extended Release Oral CapsulePSNf2f03495-12b6-457a-901f-958b9c844bfd2
729929Effexor XR 75 MG 24HR Extended Release Oral CapsulePSNf2f03495-12b6-457a-901f-958b9c844bfd2
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNf2f03495-12b6-457a-901f-958b9c844bfd2
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNf2f03495-12b6-457a-901f-958b9c844bfd2
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNf2f03495-12b6-457a-901f-958b9c844bfd2
72993124 HR venlafaxine 150 MG Extended Release Oral Capsule [Effexor]SBDf2f03495-12b6-457a-901f-958b9c844bfd2
72993224 HR venlafaxine 37.5 MG Extended Release Oral Capsule [Effexor]SBDf2f03495-12b6-457a-901f-958b9c844bfd2
72992924 HR venlafaxine 75 MG Extended Release Oral Capsule [Effexor]SBDf2f03495-12b6-457a-901f-958b9c844bfd2
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDf2f03495-12b6-457a-901f-958b9c844bfd2
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDf2f03495-12b6-457a-901f-958b9c844bfd2
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDf2f03495-12b6-457a-901f-958b9c844bfd2
72993124 HR Effexor 150 MG Extended Release Oral CapsuleSYf2f03495-12b6-457a-901f-958b9c844bfd2
72993224 HR Effexor 37.5 MG Extended Release Oral CapsuleSYf2f03495-12b6-457a-901f-958b9c844bfd2
72992924 HR Effexor 75 MG Extended Release Oral CapsuleSYf2f03495-12b6-457a-901f-958b9c844bfd2
729931Effexor XR 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral CapsuleSYf2f03495-12b6-457a-901f-958b9c844bfd2
729931Effexor XR 150 MG 24 HR Extended Release Oral CapsuleSYf2f03495-12b6-457a-901f-958b9c844bfd2
729932Effexor XR 37.5 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral CapsuleSYf2f03495-12b6-457a-901f-958b9c844bfd2
729932Effexor XR 37.5 MG 24 HR Extended Release Oral CapsuleSYf2f03495-12b6-457a-901f-958b9c844bfd2
729929Effexor XR 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral CapsuleSYf2f03495-12b6-457a-901f-958b9c844bfd2
729929Effexor XR 75 MG 24 HR Extended Release Oral CapsuleSYf2f03495-12b6-457a-901f-958b9c844bfd2
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYf2f03495-12b6-457a-901f-958b9c844bfd2
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYf2f03495-12b6-457a-901f-958b9c844bfd2
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYf2f03495-12b6-457a-901f-958b9c844bfd2
729931Effexor XR 150 MG 24HR Extended Release Oral CapsulePSN8a2302ca-5c25-4d2d-9ffe-320080934aab1
729932Effexor XR 37.5 MG 24HR Extended Release Oral CapsulePSN8a2302ca-5c25-4d2d-9ffe-320080934aab1
729929Effexor XR 75 MG 24HR Extended Release Oral CapsulePSN8a2302ca-5c25-4d2d-9ffe-320080934aab1
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN8a2302ca-5c25-4d2d-9ffe-320080934aab1
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN8a2302ca-5c25-4d2d-9ffe-320080934aab1
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN8a2302ca-5c25-4d2d-9ffe-320080934aab1
72993124 HR venlafaxine 150 MG Extended Release Oral Capsule [Effexor]SBD8a2302ca-5c25-4d2d-9ffe-320080934aab1
72993224 HR venlafaxine 37.5 MG Extended Release Oral Capsule [Effexor]SBD8a2302ca-5c25-4d2d-9ffe-320080934aab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0008-0833-02000080833021 in 1 BLISTER PACKHistorical
0008-0833-0300008083303100 BLISTER PACK in 1 CARTON (0008-0833-03) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0008-0833-02) 100 blister pack1997-11-010000-00-00NoNoCurrent
0008-0833-200000808332015 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-20) 1997-11-010000-00-00NoNoCurrent
0008-0833-210000808332130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-21) 1997-11-010000-00-00NoNoCurrent
0008-0833-220000808332290 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-22) 1997-11-010000-00-00NoNoCurrent