Venlafaxine

Product NDC
53217-245
11-digit product format
532170245
Labeler code
53217
Product ID
53217-245_a4260f17-307c-40ac-92cf-18fa8fc753de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078627
Marketing category
ANDA
Marketing start
2008-06-13
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
53217-245-302020-01-31C16284748780-19d75b9cf-dd9f-f424-e053-dadaa90a57ceVenlafaxine Tablets, USP
53217-245-602020-01-31C16284748780-19d75b9cf-dd9f-f424-e053-dadaa90a57ceVenlafaxine Tablets, USP
53217-245-902020-01-31C16284748780-19d75b9cf-dd9f-f424-e053-dadaa90a57ceVenlafaxine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-245-30Venlafaxine30 in 1 BOTTLETABLET301
53217-245-60Venlafaxine60 in 1 BOTTLETABLET601
53217-245-90Venlafaxine90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-245VENLAFAXINE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20161122_e0a6de05-2fb6-4822-ab58-f9d23862de0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314277venlafaxine HCl 50 MG Oral TabletPSNe0a6de05-2fb6-4822-ab58-f9d23862de0f1
314277venlafaxine 50 MG Oral TabletSCDe0a6de05-2fb6-4822-ab58-f9d23862de0f1
314277venlafaxine 50 MG (as venlafaxine hydrochloride 56.6 MG) Oral TabletSYe0a6de05-2fb6-4822-ab58-f9d23862de0f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-245-305321702453030 in 1 BOTTLEHistorical
53217-245-605321702456060 in 1 BOTTLEHistorical
53217-245-905321702459090 in 1 BOTTLEHistorical