FDA.reportPublic FDA data

Venlafaxine hydrochloride

Product NDC
50090-5748
11-digit product format
500905748
Labeler code
50090
Product ID
50090-5748_a5724bbe-6dd9-427e-9e20-46deb9749f39
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
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
50090-5748-02023-01-30C16284748780-1f386c649-bbc3-0266-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
50090-5748-12023-01-30C16284748780-1f386c649-bbc3-0266-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
50090-5748-0Venlafaxine hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
50090-5748-1Venlafaxine hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5748-0EA - Each50090-57482ca2c9fa-7b5b-4a52-ab58-25ce4541f58612022-08-04
50090-5748-1EA - Each50090-5748e30f47bc-c09d-4460-a38e-c7111b29931512022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5748VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20211003_63ece9a0-6692-4af7-b86a-f06ac52441b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN63ece9a0-6692-4af7-b86a-f06ac52441b71
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD63ece9a0-6692-4af7-b86a-f06ac52441b71
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY63ece9a0-6692-4af7-b86a-f06ac52441b71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5748-05009057480030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5748-0) 2021-09-290000-00-00NoNoCurrent
50090-5748-15009057480190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5748-1) 2021-09-270000-00-00NoNoCurrent