FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
65841-674
11-digit product format
658410674
Labeler code
65841
Product ID
65841-674_d4325db5-166d-4719-bdbd-a89ef8c96833
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA077653
Marketing category
ANDA
Marketing start
2008-06-13
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
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
65841-674-01Venlafaxine Hydrochloride100 in 1 BOTTLETABLET10010
65841-674-05Venlafaxine Hydrochloride500 in 1 BOTTLETABLET50010
65841-674-06Venlafaxine Hydrochloride30 in 1 BOTTLETABLET3010
65841-674-10Venlafaxine Hydrochloride1000 in 1 BOTTLETABLET100010
65841-674-14Venlafaxine Hydrochloride60 in 1 BOTTLETABLET6010
65841-674-16Venlafaxine Hydrochloride90 in 1 BOTTLETABLET9010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-674VENLAFAXINE HYDROCHLORIDE TABLET [ZYDUS LIFESCIENCES LIMITED]10Current NDC, Legacy NDC, 6 package rows20240817_51334651-7a7f-4653-bf9d-d5be04fd902d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313580venlafaxine HCl 100 MG Oral TabletPSN51334651-7a7f-4653-bf9d-d5be04fd902d10
313582venlafaxine HCl 25 MG Oral TabletPSN51334651-7a7f-4653-bf9d-d5be04fd902d10
313584venlafaxine HCl 37.5 MG Oral TabletPSN51334651-7a7f-4653-bf9d-d5be04fd902d10
314277venlafaxine HCl 50 MG Oral TabletPSN51334651-7a7f-4653-bf9d-d5be04fd902d10
313586venlafaxine HCl 75 MG Oral TabletPSN51334651-7a7f-4653-bf9d-d5be04fd902d10
313580venlafaxine 100 MG Oral TabletSCD51334651-7a7f-4653-bf9d-d5be04fd902d10
313582venlafaxine 25 MG Oral TabletSCD51334651-7a7f-4653-bf9d-d5be04fd902d10
313584venlafaxine 37.5 MG Oral TabletSCD51334651-7a7f-4653-bf9d-d5be04fd902d10
314277venlafaxine 50 MG Oral TabletSCD51334651-7a7f-4653-bf9d-d5be04fd902d10
313586venlafaxine 75 MG Oral TabletSCD51334651-7a7f-4653-bf9d-d5be04fd902d10
313580venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral TabletSY51334651-7a7f-4653-bf9d-d5be04fd902d10
313582venlafaxine 25 MG (as venlafaxine hydrochloride 28.3 MG) Oral TabletSY51334651-7a7f-4653-bf9d-d5be04fd902d10
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY51334651-7a7f-4653-bf9d-d5be04fd902d10
314277venlafaxine 50 MG (as venlafaxine hydrochloride 56.6 MG) Oral TabletSY51334651-7a7f-4653-bf9d-d5be04fd902d10
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY51334651-7a7f-4653-bf9d-d5be04fd902d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-674-0165841067401100 TABLET in 1 BOTTLE (65841-674-01) 100 tablet2008-06-130000-00-00NoNoCurrent
65841-674-0565841067405500 TABLET in 1 BOTTLE (65841-674-05) 500 tablet2008-06-130000-00-00NoNoCurrent
65841-674-066584106740630 TABLET in 1 BOTTLE (65841-674-06) 30 tablet2008-06-130000-00-00NoNoCurrent
65841-674-10658410674101000 TABLET in 1 BOTTLE (65841-674-10) 1000 tablet2008-06-130000-00-00NoNoCurrent
65841-674-146584106741460 TABLET in 1 BOTTLE (65841-674-14) 60 tablet2008-06-130000-00-00NoNoCurrent
65841-674-166584106741690 TABLET in 1 BOTTLE (65841-674-16) 90 tablet2008-06-130000-00-00NoNoCurrent