FDA.reportPublic FDA data

VENLAFAXINE HYDROCHLORIDE

Product NDC
72189-066
11-digit product format
721890066
Labeler code
72189
Product ID
72189-066_9b8e27ef-e461-604f-e053-2a95a90a7bbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA200834
Marketing category
ANDA
Marketing start
2020-01-07
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
2021-12-31
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
72189-066-302023-01-30C16284748780-1f386c64a-056b-0266-e053-dadaa90a7c1aVENLAFAXINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-066-30VENLAFAXINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-066-30EA - Each72189-066f43fc870-c31d-4993-8bae-d987aeb50f5a12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-066VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]1Legacy NDC, 1 package rows20200108_9b8e27ef-e460-604f-e053-2a95a90a7bbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN9b8e27ef-e460-604f-e053-2a95a90a7bbf1
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD9b8e27ef-e460-604f-e053-2a95a90a7bbf1
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY9b8e27ef-e460-604f-e053-2a95a90a7bbf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-066-307218900663030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-066-30) 2020-01-070000-00-00NoNoCurrent