FDA.reportPublic FDA data

VENLAFAXINE HYDROCHLORIDE

Product NDC
61919-848
11-digit product format
619190848
Labeler code
61919
Product ID
61919-848_87482806-e5fd-57c0-e053-2995a90a1fa8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
NDA020699
Marketing category
NDA
Marketing start
2014-01-01
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-848-30VENLAFAXINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-848-30EA - Each61919-84888cf5d64-e606-456b-b1af-9f3357524b2e12015-03-03

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
61919-848VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]3Legacy NDC, 1 package rows20190425_3cfc589e-455e-4df3-91e6-6cfece5c420a.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-848-306191908483030 in 1 BOTTLEHistorical