FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
68788-8825
11-digit product format
687888825
Labeler code
68788
Product ID
68788-8825_edefc932-d25d-4ead-b348-b3b6d9232091
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA216044
Marketing category
ANDA
Marketing start
2025-02-10
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
Rxcui808753

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
68788-8825-3Venlafaxine Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE301
68788-8825-6Venlafaxine Hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE601
68788-8825-9Venlafaxine Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8825-3EA - Each68788-882574557c53-e9d9-4ac6-a87d-074e3bfea27a12025-03-04
68788-8825-6EA - Each68788-882528b9d82d-5882-43fd-8c13-7c1c693ded1912025-03-04
68788-8825-9EA - Each68788-8825d5d3e1a5-9568-4f3f-b9ba-142a241c412412025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8825VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 3 package rows20250212_edefc932-d25d-4ead-b348-b3b6d9232091.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808753venlafaxine HCl 75 MG 24HR Extended Release Oral TabletPSNedefc932-d25d-4ead-b348-b3b6d92320911
80875324 HR venlafaxine 75 MG Extended Release Oral TabletSCDedefc932-d25d-4ead-b348-b3b6d92320911
808753venlafaxine 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSYedefc932-d25d-4ead-b348-b3b6d92320911
808753venlafaxine 75 MG 24 HR Extended Release Oral TabletSYedefc932-d25d-4ead-b348-b3b6d92320911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8825-36878888250330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8825-3) 2025-02-10NoNoCurrent
68788-8825-66878888250660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8825-6) 2025-02-10NoNoCurrent
68788-8825-96878888250990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8825-9) 2025-02-10NoNoCurrent