FDA.reportPublic FDA data

Venlafaxine

Product NDC
27241-221
11-digit product format
272410221
Labeler code
27241
Product ID
27241-221_a85661b9-217a-41ca-90d8-d1e29052e44d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA214691
Marketing category
ANDA
Marketing start
2023-04-12
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui808744, 808748, 808751, 808753

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27241-221-30Venlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE305
27241-221-90Venlafaxine90 in 1 BOTTLETABLET, EXTENDED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-221-30EA - Each27241-221b1b80805-d70e-45da-84f4-289c4f281de712023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-221VENLAFAXINE TABLET, EXTENDED RELEASE [AJANTA PHARMA USA INC.]4Current NDC, 2 package rows20231103_22d4817c-1f19-4490-8a38-d8904f0374f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808744venlafaxine HCl 150 MG 24HR Extended Release Oral TabletPSN22d4817c-1f19-4490-8a38-d8904f0374f75
808748venlafaxine HCl 225 MG 24HR Extended Release Oral TabletPSN22d4817c-1f19-4490-8a38-d8904f0374f75
808751venlafaxine HCl 37.5 MG 24HR Extended Release Oral TabletPSN22d4817c-1f19-4490-8a38-d8904f0374f75
808753venlafaxine HCl 75 MG 24HR Extended Release Oral TabletPSN22d4817c-1f19-4490-8a38-d8904f0374f75
80874424 HR venlafaxine 150 MG Extended Release Oral TabletSCD22d4817c-1f19-4490-8a38-d8904f0374f75
80874824 HR venlafaxine 225 MG Extended Release Oral TabletSCD22d4817c-1f19-4490-8a38-d8904f0374f75
80875124 HR venlafaxine 37.5 MG Extended Release Oral TabletSCD22d4817c-1f19-4490-8a38-d8904f0374f75
80875324 HR venlafaxine 75 MG Extended Release Oral TabletSCD22d4817c-1f19-4490-8a38-d8904f0374f75
808744venlafaxine 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY22d4817c-1f19-4490-8a38-d8904f0374f75
808744venlafaxine 150 MG 24 HR Extended Release Oral TabletSY22d4817c-1f19-4490-8a38-d8904f0374f75
808748venlafaxine 225 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY22d4817c-1f19-4490-8a38-d8904f0374f75
808748venlafaxine 225 MG 24 HR Extended Release Oral TabletSY22d4817c-1f19-4490-8a38-d8904f0374f75
808751venlafaxine 37.5 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY22d4817c-1f19-4490-8a38-d8904f0374f75
808751venlafaxine 37.5 MG 24 HR Extended Release Oral TabletSY22d4817c-1f19-4490-8a38-d8904f0374f75
808753venlafaxine 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY22d4817c-1f19-4490-8a38-d8904f0374f75
808753venlafaxine 75 MG 24 HR Extended Release Oral TabletSY22d4817c-1f19-4490-8a38-d8904f0374f75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
27241-221-302724102213030 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-221-30) 2023-04-12NoNoHistorical
27241-221-902724102219090 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-221-90) 2023-04-12NoNoHistorical