FDA.reportPublic FDA data

Venlafaxine

Product NDC
52817-134
11-digit product format
528170134
Labeler code
52817
Product ID
52817-134_8be14541-7f72-44c8-912f-5b958dbd6bdd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Trupharma, LLC
Application
ANDA202036
Marketing category
ANDA
Marketing start
2016-04-19
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
100 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
52817-134-102020-01-31C16284748780-19d75b9d0-eddf-f424-e053-dadaa90a57ceVenlafaxine Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52817-134-10Venlafaxine100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-134-10EA - Each52817-134a8679e32-e15e-4858-b272-b8f267eb53f112016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-134VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [TRUPHARMA, LLC]3Legacy NDC, 1 package rows20180221_e46f0568-3ecd-445e-b7e6-a9fb42264f13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313580venlafaxine HCl 100 MG Oral TabletPSNe46f0568-3ecd-445e-b7e6-a9fb42264f133
313582venlafaxine HCl 25 MG Oral TabletPSNe46f0568-3ecd-445e-b7e6-a9fb42264f133
313584venlafaxine HCl 37.5 MG Oral TabletPSNe46f0568-3ecd-445e-b7e6-a9fb42264f133
314277venlafaxine HCl 50 MG Oral TabletPSNe46f0568-3ecd-445e-b7e6-a9fb42264f133
313586venlafaxine HCl 75 MG Oral TabletPSNe46f0568-3ecd-445e-b7e6-a9fb42264f133
313580venlafaxine 100 MG Oral TabletSCDe46f0568-3ecd-445e-b7e6-a9fb42264f133
313582venlafaxine 25 MG Oral TabletSCDe46f0568-3ecd-445e-b7e6-a9fb42264f133
313584venlafaxine 37.5 MG Oral TabletSCDe46f0568-3ecd-445e-b7e6-a9fb42264f133
314277venlafaxine 50 MG Oral TabletSCDe46f0568-3ecd-445e-b7e6-a9fb42264f133
313586venlafaxine 75 MG Oral TabletSCDe46f0568-3ecd-445e-b7e6-a9fb42264f133
313580venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral TabletSYe46f0568-3ecd-445e-b7e6-a9fb42264f133
313582venlafaxine 25 MG (as venlafaxine hydrochloride 28.3 MG) Oral TabletSYe46f0568-3ecd-445e-b7e6-a9fb42264f133
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSYe46f0568-3ecd-445e-b7e6-a9fb42264f133
314277venlafaxine 50 MG (as venlafaxine hydrochloride 56.6 MG) Oral TabletSYe46f0568-3ecd-445e-b7e6-a9fb42264f133
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSYe46f0568-3ecd-445e-b7e6-a9fb42264f133

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52817-134-1052817013410100 in 1 BOTTLEHistorical