FDA.reportPublic FDA data

venlafaxine

Product NDC
70518-2652
11-digit product format
705182652
Labeler code
70518
Product ID
70518-2652_4a7c93b2-9399-047b-e063-6294a90af72c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090555
Marketing category
ANDA
Marketing start
2020-03-25
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
Rxcui313586

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2652-02023-03-13C16284748780-1f386c649-ae05-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP Rx only
70518-2652-12023-03-13C16284748780-1f386c649-ae05-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP Rx only
70518-2652-22023-03-13C16284748780-1f386c649-ae05-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP Rx only
70518-2652-32023-03-13C16284748780-1f386c649-ae05-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP Rx only
70518-2652-02023-01-30C16284748780-1f386c649-ae05-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP Rx only
70518-2652-12023-01-30C16284748780-1f386c649-ae05-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP Rx only
70518-2652-22023-01-30C16284748780-1f386c649-ae05-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP Rx only
70518-2652-32023-01-30C16284748780-1f386c649-ae05-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2652-0venlafaxine90 in 1 BOTTLE, PLASTICTABLET9012
70518-2652-1venlafaxine30 in 1 BLISTER PACKTABLET3012
70518-2652-2venlafaxine30 in 1 BOTTLE, PLASTICTABLET3012
70518-2652-3venlafaxine60 in 1 BOTTLE, PLASTICTABLET6012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2652VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 4 package rows20250326_f56a0f70-bbb1-4e69-b969-965a72f0e2f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313586venlafaxine HCl 75 MG Oral TabletPSNf56a0f70-bbb1-4e69-b969-965a72f0e2f012
313586venlafaxine 75 MG Oral TabletSCDf56a0f70-bbb1-4e69-b969-965a72f0e2f012
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSYf56a0f70-bbb1-4e69-b969-965a72f0e2f012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2652-07051826520090 TABLET in 1 BOTTLE, PLASTIC (70518-2652-0) 90 tablet2020-03-250000-00-00NoNoCurrent
70518-2652-17051826520130 TABLET in 1 BLISTER PACK (70518-2652-1) 30 tablet2020-03-270000-00-00NoNoCurrent
70518-2652-27051826520230 TABLET in 1 BOTTLE, PLASTIC (70518-2652-2) 30 tablet2020-12-230000-00-00NoNoCurrent
70518-2652-37051826520360 TABLET in 1 BOTTLE, PLASTIC (70518-2652-3) 60 tablet2021-02-220000-00-00NoNoCurrent