FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
71335-2495
11-digit product format
713352495
Labeler code
71335
Product ID
71335-2495_ef4fde15-e3e7-4d2e-8a21-4170c11b2eb5
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
150 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 HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313581

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
71335-2495-1Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302
71335-2495-2Venlafaxine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE602
71335-2495-3Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE902
71335-2495-4Venlafaxine Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2495-3EA - Each71335-2495a773ee0c-58cf-438e-90ce-7b4c723ff6de12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2495VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]1Current NDC, 4 package rows20240920_bce7adf8-b4b5-4d7f-bf0d-ae1277ae3a2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNbce7adf8-b4b5-4d7f-bf0d-ae1277ae3a2b2
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDbce7adf8-b4b5-4d7f-bf0d-ae1277ae3a2b2
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYbce7adf8-b4b5-4d7f-bf0d-ae1277ae3a2b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2495-17133524950130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2495-1) 2024-09-16NoNoHistorical
71335-2495-27133524950260 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2495-2) 2024-09-16NoNoHistorical
71335-2495-37133524950390 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2495-3) 2024-09-16NoNoHistorical
71335-2495-471335249504100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2495-4) 2024-09-16NoNoHistorical