FDA.reportPublic FDA data

venlafaxine hydrochloride

Product NDC
50090-5929
11-digit product format
500905929
Labeler code
50090
Product ID
50090-5929_d3a868b4-c93d-4540-89e0-395e9ec8cdad
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
2021-06-10
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
38 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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
50090-5929-02024-01-30C16284748780-11030e365-3aab-111a-e063-dadaa90a10e2These 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
50090-5929-12024-01-30C16284748780-11030e365-3aab-111a-e063-dadaa90a10e2These 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
50090-5929-0venlafaxine hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
50090-5929-1venlafaxine hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5929-0EA - Each50090-5929b1d5697b-2db0-49be-8936-c169fe52845512022-06-06
50090-5929-1EA - Each50090-592931337726-beca-4521-bf11-385b2bfa950312022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5929VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20220305_cc501daa-d20a-429f-8cb8-541eb34f8d6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNcc501daa-d20a-429f-8cb8-541eb34f8d6e1
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDcc501daa-d20a-429f-8cb8-541eb34f8d6e1
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYcc501daa-d20a-429f-8cb8-541eb34f8d6e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5929-05009059290030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5929-0) 2022-03-020000-00-00NoNoCurrent
50090-5929-15009059290190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5929-1) 2022-03-020000-00-00NoNoCurrent