FDA.reportPublic FDA data

Venlafaxine

Product NDC
70518-3820
11-digit product format
705183820
Labeler code
70518
Product ID
70518-3820_4f5c6f4c-8405-a341-e063-6394a90abda8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA214127
Marketing category
ANDA
Marketing start
2023-08-03
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui808753

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
70518-3820-0Venlafaxine90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE907
70518-3820-1Venlafaxine30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3820VENLAFAXINE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]5Current NDC, 2 package rows20241128_1ce5786e-22e6-4afa-8052-6eababc6aa4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808753venlafaxine HCl 75 MG 24HR Extended Release Oral TabletPSN1ce5786e-22e6-4afa-8052-6eababc6aa4e7
80875324 HR venlafaxine 75 MG Extended Release Oral TabletSCD1ce5786e-22e6-4afa-8052-6eababc6aa4e7
808753venlafaxine 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY1ce5786e-22e6-4afa-8052-6eababc6aa4e7
808753venlafaxine 75 MG 24 HR Extended Release Oral TabletSY1ce5786e-22e6-4afa-8052-6eababc6aa4e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-3820-07051838200090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3820-0) 2023-08-03NoNoCurrent
70518-3820-17051838200130 in 1 BOTTLE, PLASTICHistorical