FDA.reportPublic FDA data

Venlafaxine hydrochloride

Product NDC
50090-5731
11-digit product format
500905731
Labeler code
50090
Product ID
50090-5731_090e711c-61e2-4641-9424-3fc91e707d12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204889
Marketing category
ANDA
Marketing start
2017-10-06
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
75 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
50090-5731-02023-01-30C16284748780-1f386c64a-17cb-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
50090-5731-12023-01-30C16284748780-1f386c64a-17cb-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
50090-5731-0Venlafaxine hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
50090-5731-1Venlafaxine hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5731-0EA - Each50090-5731d6bd2399-d22d-48a4-95f9-327ca382578012022-08-04
50090-5731-1EA - Each50090-57318628ab67-88d5-462e-952a-729ba868660a12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5731VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20211001_5ec4b583-1b77-41b2-b1b4-795997dc7aef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN5ec4b583-1b77-41b2-b1b4-795997dc7aef1
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD5ec4b583-1b77-41b2-b1b4-795997dc7aef1
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY5ec4b583-1b77-41b2-b1b4-795997dc7aef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5731-05009057310030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5731-0) 2021-09-280000-00-00NoNoCurrent
50090-5731-15009057310190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5731-1) 2021-09-280000-00-00NoNoCurrent