Venlafaxine Hydrochloride

Product NDC
55154-0197
11-digit product format
551540197
Labeler code
55154
Product ID
55154-0197_7588ffdc-034d-4baf-9889-9a0ded265be5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA200834
Marketing category
ANDA
Marketing start
2026-03-23
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
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 HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313585

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
55154-0197-0Venlafaxine Hydrochloride10 in 1 BAGCAPSULE, EXTENDED RELEASE101
55154-0197-0Venlafaxine Hydrochloride1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN7588ffdc-034d-4baf-9889-9a0ded265be51
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD7588ffdc-034d-4baf-9889-9a0ded265be51
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY7588ffdc-034d-4baf-9889-9a0ded265be51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-0197-05515401970010 BLISTER PACK in 1 BAG (55154-0197-0) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2026-03-23NoNoCurrent