FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
0093-9147
11-digit product format
000939147
Labeler code
0093
Product ID
0093-9147_da23a2ab-f20e-4208-b72b-d50260b97923
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA076690
Marketing category
ANDA
Marketing start
2006-08-04
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313580, 313582, 313584, 313586, 314277

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
0093-9147-01Venlafaxine Hydrochloride100 in 1 BOTTLETABLET10012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-9147VENLAFAXINE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA, INC.]12Current NDC, Legacy NDC, 1 package rows20231108_37aaa8ac-4e0c-4e04-98b5-19b0d90d857c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313580venlafaxine HCl 100 MG Oral TabletPSN37aaa8ac-4e0c-4e04-98b5-19b0d90d857c12
313582venlafaxine HCl 25 MG Oral TabletPSN37aaa8ac-4e0c-4e04-98b5-19b0d90d857c12
313584venlafaxine HCl 37.5 MG Oral TabletPSN37aaa8ac-4e0c-4e04-98b5-19b0d90d857c12
314277venlafaxine HCl 50 MG Oral TabletPSN37aaa8ac-4e0c-4e04-98b5-19b0d90d857c12
313586venlafaxine HCl 75 MG Oral TabletPSN37aaa8ac-4e0c-4e04-98b5-19b0d90d857c12
313580venlafaxine 100 MG Oral TabletSCD37aaa8ac-4e0c-4e04-98b5-19b0d90d857c12
313582venlafaxine 25 MG Oral TabletSCD37aaa8ac-4e0c-4e04-98b5-19b0d90d857c12
313584venlafaxine 37.5 MG Oral TabletSCD37aaa8ac-4e0c-4e04-98b5-19b0d90d857c12
314277venlafaxine 50 MG Oral TabletSCD37aaa8ac-4e0c-4e04-98b5-19b0d90d857c12
313586venlafaxine 75 MG Oral TabletSCD37aaa8ac-4e0c-4e04-98b5-19b0d90d857c12
313580venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral TabletSY37aaa8ac-4e0c-4e04-98b5-19b0d90d857c12
313582venlafaxine 25 MG (as venlafaxine hydrochloride 28.3 MG) Oral TabletSY37aaa8ac-4e0c-4e04-98b5-19b0d90d857c12
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY37aaa8ac-4e0c-4e04-98b5-19b0d90d857c12
314277venlafaxine 50 MG (as venlafaxine hydrochloride 56.6 MG) Oral TabletSY37aaa8ac-4e0c-4e04-98b5-19b0d90d857c12
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY37aaa8ac-4e0c-4e04-98b5-19b0d90d857c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-9147-0100093914701100 TABLET in 1 BOTTLE (0093-9147-01) 100 tablet2006-08-040000-00-00NoNoCurrent