FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
70518-4065
11-digit product format
705184065
Labeler code
70518
Product ID
70518-4065_3fa2c2e6-f238-6e07-e063-6394a90a86d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA216044
Marketing category
ANDA
Marketing start
2024-05-04
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
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
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4065-0Venlafaxine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4065VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]1Current NDC, 1 package rows20240508_9df3a51c-1b89-4d2a-8f41-3755910e9bfb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808753venlafaxine HCl 75 MG 24HR Extended Release Oral TabletPSN9df3a51c-1b89-4d2a-8f41-3755910e9bfb2
80875324 HR venlafaxine 75 MG Extended Release Oral TabletSCD9df3a51c-1b89-4d2a-8f41-3755910e9bfb2
808753venlafaxine 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY9df3a51c-1b89-4d2a-8f41-3755910e9bfb2
808753venlafaxine 75 MG 24 HR Extended Release Oral TabletSY9df3a51c-1b89-4d2a-8f41-3755910e9bfb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4065-07051840650090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4065-0) 2024-05-04NoNoHistorical