FDA.reportPublic FDA data

Venlafaxine hydrochloride

Product NDC
50090-5725
11-digit product format
500905725
Labeler code
50090
Product ID
50090-5725_0664260d-049f-491f-b24a-1f5157e31474
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
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
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
50090-5725-02023-01-30C16284748780-1f386c64a-2113-0266-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
50090-5725-12023-01-30C16284748780-1f386c64a-2113-0266-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
50090-5725-0Venlafaxine hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
50090-5725-1Venlafaxine hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5725-0EA - Each50090-57250ab9db0a-5009-4baf-a8b8-1c507ad2c4a912022-08-04
50090-5725-1EA - Each50090-572562450b3e-ad93-4029-a8ab-cbe8e579e4f012022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5725VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20211001_c0298208-bdd0-4de6-bdb3-e17d03ec9659.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNc0298208-bdd0-4de6-bdb3-e17d03ec96591
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDc0298208-bdd0-4de6-bdb3-e17d03ec96591
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYc0298208-bdd0-4de6-bdb3-e17d03ec96591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5725-05009057250030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5725-0) 2021-09-280000-00-00NoNoCurrent
50090-5725-15009057250190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5725-1) 2021-09-280000-00-00NoNoCurrent