FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
71335-2421
11-digit product format
713352421
Labeler code
71335
Product ID
71335-2421_ebaa2be0-2d61-4ebf-8178-5a92c7d059c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214654
Marketing category
ANDA
Marketing start
2022-09-07
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
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
71335-2421-1Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE902
71335-2421-2Venlafaxine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE602
71335-2421-3Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302
71335-2421-4Venlafaxine Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1002
71335-2421-5Venlafaxine Hydrochloride7 in 1 BOTTLECAPSULE, EXTENDED RELEASE72

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2421-1EA - Each71335-24210f8ee009-dca3-4c31-afc8-c4f4b4fe7cb712025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2421VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]1Current NDC, 5 package rows20240704_ea5914ab-28f3-4cb3-bade-6eaccac214e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNea5914ab-28f3-4cb3-bade-6eaccac214e42
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDea5914ab-28f3-4cb3-bade-6eaccac214e42
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYea5914ab-28f3-4cb3-bade-6eaccac214e42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2421-17133524210190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2421-1) 2024-06-26NoNoCurrent
71335-2421-27133524210260 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2421-2) 2024-06-26NoNoCurrent
71335-2421-37133524210330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2421-3) 2024-06-26NoNoCurrent
71335-2421-471335242104100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2421-4) 2024-06-26NoNoCurrent
71335-2421-5713352421057 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2421-5) 2024-06-26NoNoCurrent