FDA.reportPublic FDA data

Venlafaxine hydrochloride

Product NDC
33342-194
11-digit product format
333420194
Labeler code
33342
Product ID
33342-194_ea9c3795-420f-49fb-918c-7033a1f06963
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA204889
Marketing category
ANDA
Marketing start
2017-10-06
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
37.5 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 HYDROCHLORIDE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313581, 313583, 313585

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
33342-194-07Venlafaxine hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE307
33342-194-10Venlafaxine hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE907
33342-194-11Venlafaxine hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1007
33342-194-12Venlafaxine hydrochloride10 in 1 CARTONCAPSULE, EXTENDED RELEASE107
33342-194-12Venlafaxine hydrochloride10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE107
33342-194-15Venlafaxine hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-194-07EA - Each33342-194dc527543-040f-4f98-822b-d2b03538af4b12018-07-03
33342-194-10EA - Each33342-194fd23028d-61f8-4b56-8886-6128923b35d312021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-194VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MACLEODS PHARMACEUTICALS LIMITED]7Current NDC, Legacy NDC, 6 package rows20230921_3e51f786-3691-4ec4-836b-7f2c9a385aa7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN3e51f786-3691-4ec4-836b-7f2c9a385aa77
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN3e51f786-3691-4ec4-836b-7f2c9a385aa77
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN3e51f786-3691-4ec4-836b-7f2c9a385aa77
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD3e51f786-3691-4ec4-836b-7f2c9a385aa77
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD3e51f786-3691-4ec4-836b-7f2c9a385aa77
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD3e51f786-3691-4ec4-836b-7f2c9a385aa77
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY3e51f786-3691-4ec4-836b-7f2c9a385aa77
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY3e51f786-3691-4ec4-836b-7f2c9a385aa77
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY3e51f786-3691-4ec4-836b-7f2c9a385aa77
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN63ece9a0-6692-4af7-b86a-f06ac52441b71
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD63ece9a0-6692-4af7-b86a-f06ac52441b71
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY63ece9a0-6692-4af7-b86a-f06ac52441b71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-194-073334201940730 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-194-07) 2017-10-060000-00-00NoNoCurrent
33342-194-103334201941090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-194-10) 2018-08-140000-00-00NoNoCurrent
33342-194-1133342019411100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-194-11) 2018-08-140000-00-00NoNoCurrent
33342-194-123334201941210 BLISTER PACK in 1 CARTON (33342-194-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2017-10-060000-00-00NoNoCurrent
33342-194-1533342019415500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-194-15) 2017-10-060000-00-00NoNoCurrent