FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
80425-0396
11-digit product format
804250396
Labeler code
80425
Product ID
80425-0396_19b15238-1c3c-6646-e063-6394a90a55bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA214654
Marketing category
ANDA
Marketing start
2024-05-24
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 Hydrochloride
Listing expiration
2026-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0396-1Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
80425-0396-2Venlafaxine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE601
80425-0396-3Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0396-1EA - Each80425-0396e0b20590-ad01-476a-ab10-3a49eaadb99512024-07-12
80425-0396-2EA - Each80425-03964bf10b98-cb2b-4df0-9119-0597dec20d7812024-07-12
80425-0396-3EA - Each80425-0396cc37e142-5029-412d-8832-cd1e48550d9a12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0396VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]1Current NDC, 3 package rows20240601_19b1543e-d599-a869-e063-6294a90a8e28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN19b1543e-d599-a869-e063-6294a90a8e281
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD19b1543e-d599-a869-e063-6294a90a8e281
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY19b1543e-d599-a869-e063-6294a90a8e281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0396-18042503960130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0396-1) 2024-05-24NoNoHistorical
80425-0396-28042503960260 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0396-2) 2024-05-24NoNoHistorical
80425-0396-38042503960390 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0396-3) 2024-05-24NoNoHistorical