FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
13811-715
11-digit product format
138110715
Labeler code
13811
Product ID
13811-715_55564637-0e7a-4684-be84-9d8c4cecacc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Trigen Laboratories, LLC
Application
NDA022104
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2010-04-29
Marketing end
2026-09-30
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
225 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Venlafaxine Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE225 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui808744, 808748, 808751, 808753

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
13811-715-30Venlafaxine Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE3014
13811-715-90Venlafaxine Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13811-715-30EA - Each13811-715ca910132-8b62-4aff-bced-6d52c610afd212016-12-07
13811-715-90EA - Each13811-715fae975af-c329-40a5-aa09-d971af01b9bb12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13811-715VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [TRIGEN LABORATORIES, LLC]11Current NDC, Legacy NDC, 2 package rows20240606_fdaed1c2-dd0a-4bf3-975a-86fe3e7f0c97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808744venlafaxine HCl 150 MG 24HR Extended Release Oral TabletPSNfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
808748venlafaxine HCl 225 MG 24HR Extended Release Oral TabletPSNfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
808751venlafaxine HCl 37.5 MG 24HR Extended Release Oral TabletPSNfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
808753venlafaxine HCl 75 MG 24HR Extended Release Oral TabletPSNfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
80874424 HR venlafaxine 150 MG Extended Release Oral TabletSCDfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
80874824 HR venlafaxine 225 MG Extended Release Oral TabletSCDfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
80875124 HR venlafaxine 37.5 MG Extended Release Oral TabletSCDfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
80875324 HR venlafaxine 75 MG Extended Release Oral TabletSCDfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
808744venlafaxine 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSYfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
808744venlafaxine 150 MG 24 HR Extended Release Oral TabletSYfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
808748venlafaxine 225 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSYfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
808748venlafaxine 225 MG 24 HR Extended Release Oral TabletSYfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
808751venlafaxine 37.5 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSYfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
808751venlafaxine 37.5 MG 24 HR Extended Release Oral TabletSYfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
808753venlafaxine 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSYfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
808753venlafaxine 75 MG 24 HR Extended Release Oral TabletSYfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13811-715-301381107153030 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-715-30) 2010-04-292026-09-30NoNoCurrent
13811-715-901381107159090 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-715-90) 2010-04-290000-00-00NoNoCurrent