FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
71335-2971
11-digit product format
713352971
Labeler code
71335
Product ID
71335-2971_af5af284-b2f1-48e5-a220-210139e39471
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA217390
Marketing category
ANDA
Marketing start
2023-09-25
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Venlafaxine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313585

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
71335-2971-1Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE902
71335-2971-2Venlafaxine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE602
71335-2971-3Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302
71335-2971-4Venlafaxine Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1002
71335-2971-5Venlafaxine Hydrochloride7 in 1 BOTTLECAPSULE, EXTENDED RELEASE72

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNe2fa1bb0-ab86-4499-84cb-ff5e02a169912
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDe2fa1bb0-ab86-4499-84cb-ff5e02a169912
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYe2fa1bb0-ab86-4499-84cb-ff5e02a169912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2971-17133529710190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2971-1) 2025-10-28NoNoHistorical
71335-2971-27133529710260 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2971-2) 2025-10-28NoNoHistorical
71335-2971-37133529710330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2971-3) 2025-10-28NoNoHistorical
71335-2971-471335297104100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2971-4) 2025-10-28NoNoHistorical
71335-2971-5713352971057 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2971-5) 2025-10-28NoNoHistorical