FDA.reportPublic FDA data

VENLAFAXINE HYDROCHLORIDE

Product NDC
61919-427
11-digit product format
619190427
Labeler code
61919
Product ID
61919-427_908dc8d9-6c95-0c40-e053-2a95a90a2e57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA090174
Marketing category
ANDA
Marketing start
2019-08-20
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
2020-12-31
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
61919-427-602021-01-29C16284748780-1ba0f9c33-51a1-a910-e053-dadaa90a0b85VENLAFAXINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-427-30VENLAFAXINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303
61919-427-60VENLAFAXINE HYDROCHLORIDE60 in 1 BOTTLECAPSULE, EXTENDED RELEASE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-427-30EA - Each61919-42734e6a4c7-185e-438a-a957-913bd5501ec312019-08-06
61919-427-60EA - Each61919-427106ff379-d287-46ba-95c3-3ba9dbed42c012019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]1
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]1
ETHYLCELLULOSE (100 MPA.S)INACTIVE INGREDIENT47MLB0F1MVVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]1
GELATININACTIVE INGREDIENT2G86QN327LVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-427VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]3Legacy NDC, 1 package rows20190425_3cfc589e-455e-4df3-91e6-6cfece5c420a.zip
61919-427VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT_RX]1Legacy NDC, 1 package rows20220919_908dc8d9-6c94-0c40-e053-2a95a90a2e57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN3cfc589e-455e-4df3-91e6-6cfece5c420a3
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN3cfc589e-455e-4df3-91e6-6cfece5c420a3
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD3cfc589e-455e-4df3-91e6-6cfece5c420a3
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD3cfc589e-455e-4df3-91e6-6cfece5c420a3
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY3cfc589e-455e-4df3-91e6-6cfece5c420a3
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY3cfc589e-455e-4df3-91e6-6cfece5c420a3
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN908dc8d9-6c94-0c40-e053-2a95a90a2e571
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD908dc8d9-6c94-0c40-e053-2a95a90a2e571
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY908dc8d9-6c94-0c40-e053-2a95a90a2e571

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-427-306191904273030 in 1 BOTTLEHistorical
61919-427-606191904276060 in 1 BOTTLEHistorical