FDA.reportPublic FDA data

VENLAFAXINE HYDROCHLORIDE

Product NDC
71921-172
11-digit product format
719210172
Labeler code
71921
Product ID
71921-172_f06f84fb-b574-4f19-bf21-5ae0c56c2116
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Florida Pharmaceutical Products, LLC
Application
ANDA203332
Marketing category
ANDA
Marketing start
2020-03-20
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
38 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
2023-12-31
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
71921-172-032024-01-30C16284748780-11030e365-39bf-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE extended-release capsules, for oral use. Initial U.S. Approval:1997
71921-172-092024-01-30C16284748780-11030e365-39bf-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE extended-release capsules, for oral use. Initial U.S. Approval:1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71921-172-03VENLAFAXINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE, EXTENDED RELEASE304
71921-172-09VENLAFAXINE HYDROCHLORIDE90 in 1 BOTTLECAPSULE, EXTENDED RELEASE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71921-172VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [FLORIDA PHARMACEUTICAL PRODUCTS, LLC]4Legacy NDC, 2 package rows20221227_86becd78-f566-471d-b04e-ddb24c8f194c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN86becd78-f566-471d-b04e-ddb24c8f194c4
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN86becd78-f566-471d-b04e-ddb24c8f194c4
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN86becd78-f566-471d-b04e-ddb24c8f194c4
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD86becd78-f566-471d-b04e-ddb24c8f194c4
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD86becd78-f566-471d-b04e-ddb24c8f194c4
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD86becd78-f566-471d-b04e-ddb24c8f194c4
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY86becd78-f566-471d-b04e-ddb24c8f194c4
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY86becd78-f566-471d-b04e-ddb24c8f194c4
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY86becd78-f566-471d-b04e-ddb24c8f194c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71921-172-037192101720330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71921-172-03) 2020-03-200000-00-00NoNoCurrent
71921-172-097192101720990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71921-172-09) 2020-03-200000-00-00NoNoCurrent
71921-172-337192101723330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71921-172-33) 2020-03-200000-00-00NoNoCurrent