FDA.reportPublic FDA data

venlafaxine

Product NDC
71335-0778
11-digit product format
713350778
Labeler code
71335
Product ID
71335-0778_a90443c0-5875-46af-857d-1fdae8c8ad0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078932
Marketing category
ANDA
Marketing start
2015-10-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
venlafaxine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313586

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
71335-0778-1venlafaxine60 in 1 BOTTLETABLET60102
71335-0778-2venlafaxine30 in 1 BOTTLETABLET30102
71335-0778-3venlafaxine90 in 1 BOTTLETABLET90102
71335-0778-4venlafaxine28 in 1 BOTTLETABLET28102
71335-0778-5venlafaxine120 in 1 BOTTLETABLET120102
71335-0778-6venlafaxine100 in 1 BOTTLETABLET100102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0778-2EA - Each71335-07786414d219-c0f9-4d4e-91df-efcd273b808512025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0778VENLAFAXINE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 6 package rows20240524_0c9511a2-c581-44cd-bf38-a751fcc658e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313586venlafaxine HCl 75 MG Oral TabletPSN0c9511a2-c581-44cd-bf38-a751fcc658e4102
313586venlafaxine 75 MG Oral TabletSCD0c9511a2-c581-44cd-bf38-a751fcc658e4102
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY0c9511a2-c581-44cd-bf38-a751fcc658e4102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0778-17133507780160 TABLET in 1 BOTTLE (71335-0778-1) 60 tablet2022-02-090000-00-00NoNoCurrent
71335-0778-27133507780230 TABLET in 1 BOTTLE (71335-0778-2) 30 tablet2022-02-090000-00-00NoNoCurrent
71335-0778-37133507780390 TABLET in 1 BOTTLE (71335-0778-3) 90 tablet2022-02-090000-00-00NoNoCurrent
71335-0778-47133507780428 TABLET in 1 BOTTLE (71335-0778-4) 28 tablet2022-02-090000-00-00NoNoCurrent
71335-0778-571335077805120 TABLET in 1 BOTTLE (71335-0778-5) 120 tablet2022-02-090000-00-00NoNoCurrent
71335-0778-671335077806100 TABLET in 1 BOTTLE (71335-0778-6) 100 tablet2022-02-090000-00-00NoNoCurrent