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

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) 2025-02-10NoNoHistorical
68788-8825-66878888250660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8825-6) 2025-02-10NoNoHistorical
68788-8825-96878888250990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8825-9) 2025-02-10NoNoHistorical