FDA.reportPublic FDA data

venlafaxine

Product NDC
71335-1104
11-digit product format
713351104
Labeler code
71335
Product ID
71335-1104_6feb7962-b69c-40d9-a853-f2ea11ae333f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090555
Marketing category
ANDA
Marketing start
2010-04-07
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
71335-1104-1venlafaxine60 in 1 BOTTLETABLET606
71335-1104-2venlafaxine30 in 1 BOTTLETABLET306
71335-1104-3venlafaxine90 in 1 BOTTLETABLET906
71335-1104-4venlafaxine28 in 1 BOTTLETABLET286
71335-1104-5venlafaxine120 in 1 BOTTLETABLET1206
71335-1104-6venlafaxine100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1104-1EA - Each71335-1104deb9ef7f-b303-4227-809a-2f091372b13c12019-10-07
71335-1104-2EA - Each71335-1104bfa1a46e-3601-4ab2-866a-0aff9dc0ef4312020-09-14
71335-1104-4EA - Each71335-110458a5ceaa-5470-4fb2-ab49-81b2af4eca5e12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1104VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 6 package rows20240525_304bda24-9151-47b5-9f62-005ea325a11e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313586venlafaxine HCl 75 MG Oral TabletPSN304bda24-9151-47b5-9f62-005ea325a11e6
313586venlafaxine 75 MG Oral TabletSCD304bda24-9151-47b5-9f62-005ea325a11e6
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY304bda24-9151-47b5-9f62-005ea325a11e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1104-17133511040160 TABLET in 1 BOTTLE (71335-1104-1) 60 tablet2019-02-200000-00-00NoNoCurrent
71335-1104-27133511040230 TABLET in 1 BOTTLE (71335-1104-2) 30 tablet2019-02-130000-00-00NoNoCurrent
71335-1104-37133511040390 TABLET in 1 BOTTLE (71335-1104-3) 90 tablet2020-01-030000-00-00NoNoCurrent
71335-1104-47133511040428 TABLET in 1 BOTTLE (71335-1104-4) 28 tablet2021-12-280000-00-00NoNoCurrent
71335-1104-571335110405120 TABLET in 1 BOTTLE (71335-1104-5) 120 tablet2021-12-280000-00-00NoNoCurrent
71335-1104-671335110406100 TABLET in 1 BOTTLE (71335-1104-6) 100 tablet2021-12-280000-00-00NoNoCurrent