FDA.reportPublic FDA data

Effexor

Product NDC
58151-125
11-digit product format
581510125
Labeler code
58151
Product ID
58151-125_2319042f-5d24-42d3-9b0a-8893bed66813
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Viatris Specialty LLC
Application
NDA020699
Marketing category
NDA
Marketing start
2024-07-17
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
37.5 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Effexor
Brand name suffix
XR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313581, 313583, 313585, 729929, 729931, 729932

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
58151-125-77EffexorXR90 in 1 BOTTLECAPSULE, EXTENDED RELEASE907
58151-125-93EffexorXR30 in 1 BOTTLECAPSULE, EXTENDED RELEASE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58151-125-77EA - Each58151-125e1be541d-74d3-432c-9b3c-78bc11fd313a12024-08-12
58151-125-93EA - Each58151-1258fc7306e-ca9b-4871-86de-01133bfd5c2412024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-125EFFEXOR XR (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VIATRIS SPECIALTY LLC]6Current NDC, 2 package rows20241101_c848a5d8-ba94-4c84-80e3-0bf35fb8e32e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
729931Effexor XR 150 MG 24HR Extended Release Oral CapsulePSNc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
729932Effexor XR 37.5 MG 24HR Extended Release Oral CapsulePSNc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
729929Effexor XR 75 MG 24HR Extended Release Oral CapsulePSNc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
72993124 HR venlafaxine 150 MG Extended Release Oral Capsule [Effexor]SBDc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
72993224 HR venlafaxine 37.5 MG Extended Release Oral Capsule [Effexor]SBDc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
72992924 HR venlafaxine 75 MG Extended Release Oral Capsule [Effexor]SBDc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
72993124 HR Effexor 150 MG Extended Release Oral CapsuleSYc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
72993224 HR Effexor 37.5 MG Extended Release Oral CapsuleSYc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
72992924 HR Effexor 75 MG Extended Release Oral CapsuleSYc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
729931Effexor XR 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral CapsuleSYc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
729931Effexor XR 150 MG 24 HR Extended Release Oral CapsuleSYc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
729932Effexor XR 37.5 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral CapsuleSYc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
729932Effexor XR 37.5 MG 24 HR Extended Release Oral CapsuleSYc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
729929Effexor XR 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral CapsuleSYc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
729929Effexor XR 75 MG 24 HR Extended Release Oral CapsuleSYc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
58151-125-775815101257790 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58151-125-77) 2024-07-17NoNoCurrent
58151-125-935815101259330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58151-125-93) 2024-07-17NoNoCurrent