FDA.reportPublic FDA data

venlafaxine

Product NDC
70518-1385
11-digit product format
705181385
Labeler code
70518
Product ID
70518-1385_48fb8b01-4fa8-be3f-e063-6394a90a0659
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090555
Marketing category
ANDA
Marketing start
2018-08-24
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
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 HYDROCHLORIDE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313584

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
70518-1385-0venlafaxine30 in 1 BLISTER PACKTABLET3018
70518-1385-1venlafaxine90 in 1 BOTTLE, PLASTICTABLET9018
70518-1385-2venlafaxine30 in 1 BOTTLE, PLASTICTABLET3018
70518-1385-3venlafaxine60 in 1 BOTTLE, PLASTICTABLET6018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1385VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [REMEDYREPACK INC.]14Current NDC, Legacy NDC, 4 package rows20250223_4a82cef5-693e-46e9-90c4-bff753cdce37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313584venlafaxine HCl 37.5 MG Oral TabletPSN4a82cef5-693e-46e9-90c4-bff753cdce3718
313584venlafaxine 37.5 MG Oral TabletSCD4a82cef5-693e-46e9-90c4-bff753cdce3718
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY4a82cef5-693e-46e9-90c4-bff753cdce3718

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1385-07051813850030 TABLET in 1 BLISTER PACK (70518-1385-0) 30 tablet2018-08-240000-00-00NoNoCurrent
70518-1385-17051813850190 TABLET in 1 BOTTLE, PLASTIC (70518-1385-1) 90 tablet2018-10-040000-00-00NoNoCurrent
70518-1385-27051813850230 TABLET in 1 BOTTLE, PLASTIC (70518-1385-2) 30 tablet2021-02-010000-00-00NoNoCurrent
70518-1385-37051813850360 TABLET in 1 BOTTLE, PLASTIC (70518-1385-3) 60 tablet2023-11-07NoNoCurrent