FDA.reportPublic FDA data

venlafaxine

Product NDC
57237-174
11-digit product format
572370174
Labeler code
57237
Product ID
57237-174_4da7fe70-bb28-43f2-97b6-66d130e6c72f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA090555
Marketing category
ANDA
Marketing start
2010-04-07
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
50 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE50 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
57237-174-01venlafaxine100 in 1 BOTTLETABLET1008
57237-174-90venlafaxine90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-174-01EA - Each57237-174d1a971a8-2a73-4586-ad58-a4b4a40e6c3012016-05-16
57237-174-90EA - Each57237-17441c7ac37-6b1e-4ca3-8c10-fdda1100da9312016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-174VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [RISING PHARMA HOLDINGS, INC.]8Current NDC, Legacy NDC, 2 package rows20230908_20319949-ccf9-477a-a6e3-53502772deb9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314277venlafaxine HCl 50 MG Oral TabletPSNb19ec628-4034-4316-ad3d-46c1ee22072814
314277venlafaxine 50 MG Oral TabletSCDb19ec628-4034-4316-ad3d-46c1ee22072814
314277venlafaxine 50 MG (as venlafaxine hydrochloride 56.6 MG) Oral TabletSYb19ec628-4034-4316-ad3d-46c1ee22072814
313580venlafaxine HCl 100 MG Oral TabletPSN20319949-ccf9-477a-a6e3-53502772deb98
313582venlafaxine HCl 25 MG Oral TabletPSN20319949-ccf9-477a-a6e3-53502772deb98
313584venlafaxine HCl 37.5 MG Oral TabletPSN20319949-ccf9-477a-a6e3-53502772deb98
314277venlafaxine HCl 50 MG Oral TabletPSN20319949-ccf9-477a-a6e3-53502772deb98
313586venlafaxine HCl 75 MG Oral TabletPSN20319949-ccf9-477a-a6e3-53502772deb98
313580venlafaxine 100 MG Oral TabletSCD20319949-ccf9-477a-a6e3-53502772deb98
313582venlafaxine 25 MG Oral TabletSCD20319949-ccf9-477a-a6e3-53502772deb98
313584venlafaxine 37.5 MG Oral TabletSCD20319949-ccf9-477a-a6e3-53502772deb98
314277venlafaxine 50 MG Oral TabletSCD20319949-ccf9-477a-a6e3-53502772deb98
313586venlafaxine 75 MG Oral TabletSCD20319949-ccf9-477a-a6e3-53502772deb98
313580venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral TabletSY20319949-ccf9-477a-a6e3-53502772deb98
313582venlafaxine 25 MG (as venlafaxine hydrochloride 28.3 MG) Oral TabletSY20319949-ccf9-477a-a6e3-53502772deb98
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY20319949-ccf9-477a-a6e3-53502772deb98
314277venlafaxine 50 MG (as venlafaxine hydrochloride 56.6 MG) Oral TabletSY20319949-ccf9-477a-a6e3-53502772deb98
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY20319949-ccf9-477a-a6e3-53502772deb98

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-174-0157237017401100 TABLET in 1 BOTTLE (57237-174-01) 100 tablet2010-04-070000-00-00NoNoCurrent
57237-174-905723701749090 TABLET in 1 BOTTLE (57237-174-90) 90 tablet2010-04-070000-00-00NoNoCurrent