FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
53002-1361
11-digit product format
530021361
Labeler code
53002
Product ID
53002-1361_2b395815-30a0-4b98-8865-42cfc4f3386e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA076565
Marketing category
ANDA
Marketing start
2010-07-01
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
150 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
2021-12-31
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
53002-1361-32025-01-30C16284748780-19d75b9d0-c718-f424-e053-dadaa90a57ceThese 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
53002-1361-92025-01-30C16284748780-19d75b9d0-c718-f424-e053-dadaa90a57ceThese 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
53002-1361-32023-06-08C16284748780-19d75b9d0-c718-f424-e053-dadaa90a57ceThese 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
53002-1361-92023-06-08C16284748780-19d75b9d0-c718-f424-e053-dadaa90a57ceThese 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
53002-1361-32023-01-30C16284748780-19d75b9d0-c718-f424-e053-dadaa90a57ceThese 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
53002-1361-92023-01-30C16284748780-19d75b9d0-c718-f424-e053-dadaa90a57ceThese 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
53002-1361-32020-12-29C16284748780-19d75b9d0-c718-f424-e053-dadaa90a57ceThese 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
53002-1361-92020-12-29C16284748780-19d75b9d0-c718-f424-e053-dadaa90a57ceThese 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
53002-1361-32020-01-31C16284748780-19d75b9d0-c718-f424-e053-dadaa90a57ceThese 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
53002-1361-92020-01-31C16284748780-19d75b9d0-c718-f424-e053-dadaa90a57ceThese 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
53002-1361-3Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE309
53002-1361-9Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1361VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [RPK PHARMACEUTICALS, INC.]9Legacy NDC, 2 package rows20230609_26e77725-8be7-402a-ad2d-ea2081cb3711.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN26e77725-8be7-402a-ad2d-ea2081cb37119
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN26e77725-8be7-402a-ad2d-ea2081cb37119
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN26e77725-8be7-402a-ad2d-ea2081cb37119
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD26e77725-8be7-402a-ad2d-ea2081cb37119
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD26e77725-8be7-402a-ad2d-ea2081cb37119
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD26e77725-8be7-402a-ad2d-ea2081cb37119
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY26e77725-8be7-402a-ad2d-ea2081cb37119
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY26e77725-8be7-402a-ad2d-ea2081cb37119
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY26e77725-8be7-402a-ad2d-ea2081cb37119

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-1361-35300213610330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53002-1361-3) 2017-09-010000-00-00NoNoCurrent
53002-1361-95300213610990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53002-1361-9) 2017-09-010000-00-00NoNoCurrent