FDA.reportPublic FDA data

venlafaxine hydrochloride

Product NDC
50090-2886
11-digit product format
500902886
Labeler code
50090
Product ID
50090-2886_3743ed9e-a7fd-4e0a-8645-8e40f17c096d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090174
Marketing category
ANDA
Marketing start
2011-06-01
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
38 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
2022-12-31
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
50090-2886-02023-01-30C16284748780-1f386c649-a4a7-0266-e053-dadaa90a7c1aThese 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
50090-2886-12023-01-30C16284748780-1f386c649-a4a7-0266-e053-dadaa90a7c1aThese 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
50090-2886-0venlafaxine hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3018
50090-2886-1venlafaxine hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2886-0EA - Each50090-288685f45632-9a34-447a-ac48-e96d2999280212019-04-11
50090-2886-1EA - Each50090-28861ddd622a-85a7-4f6c-9988-857d7862c75912021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2886VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]18Legacy NDC, 2 package rows20210818_b49a550b-cd80-4e24-9ae9-52d362e36bdf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNb49a550b-cd80-4e24-9ae9-52d362e36bdf18
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNb49a550b-cd80-4e24-9ae9-52d362e36bdf18
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDb49a550b-cd80-4e24-9ae9-52d362e36bdf18
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDb49a550b-cd80-4e24-9ae9-52d362e36bdf18
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYb49a550b-cd80-4e24-9ae9-52d362e36bdf18
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYb49a550b-cd80-4e24-9ae9-52d362e36bdf18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2886-05009028860030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-2886-0) 2017-02-280000-00-00NoNoCurrent
50090-2886-15009028860190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-2886-1) 2020-11-100000-00-00NoNoCurrent