FDA.reportPublic FDA data

venlafaxine hydrochloride

Product NDC
53217-194
11-digit product format
532170194
Labeler code
53217
Product ID
53217-194_915aabb9-bf7a-445d-a1e4-ba26bc2436af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA090174
Marketing category
ANDA
Marketing start
2011-06-01
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
E
Listing certified through
2018-12-31
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
53217-194-012020-01-31C16284748780-19d75b9d1-1c80-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, USP for oral use Initial U.S. Approval: 1997
53217-194-052020-01-31C16284748780-19d75b9d1-1c80-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, USP for oral use Initial U.S. Approval: 1997
53217-194-302020-01-31C16284748780-19d75b9d1-1c80-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, USP for oral use Initial U.S. Approval: 1997
53217-194-602020-01-31C16284748780-19d75b9d1-1c80-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, USP for oral use Initial U.S. Approval: 1997
53217-194-902020-01-31C16284748780-19d75b9d1-1c80-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, USP for oral use Initial U.S. Approval: 1997
53217-194-932020-01-31C16284748780-19d75b9d1-1c80-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, USP for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-194-01venlafaxine hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1001
53217-194-05venlafaxine hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5001
53217-194-30venlafaxine hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
53217-194-60venlafaxine hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE601
53217-194-90venlafaxine hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901
53217-194-93venlafaxine hydrochloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-194-30EA - Each53217-194c8aaa19a-db85-4835-a849-a9147da82a3812016-07-19
53217-194-60EA - Each53217-1949bce6ccc-3413-41ed-8879-849a4921381712016-07-19
53217-194-90EA - Each53217-194febca2b8-3e29-4bdc-9dd1-8de39fb367a012016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-194VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 6 package rows20160623_af375db8-94ff-44c9-a625-c82a5011955e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNaf375db8-94ff-44c9-a625-c82a5011955e1
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDaf375db8-94ff-44c9-a625-c82a5011955e1
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYaf375db8-94ff-44c9-a625-c82a5011955e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-194-0153217019401100 in 1 BOTTLEHistorical
53217-194-0553217019405500 in 1 BOTTLEHistorical
53217-194-305321701943030 in 1 BOTTLEHistorical
53217-194-605321701946060 in 1 BOTTLEHistorical
53217-194-905321701949090 in 1 BOTTLEHistorical
53217-194-93532170194931000 in 1 BOTTLEHistorical