FDA.reportPublic FDA data

VENLAFAXINE HYDROCHLORIDE

Product NDC
61919-920
11-digit product format
619190920
Labeler code
61919
Product ID
61919-920_b6cc4b45-4847-4334-9ce9-81fffcb96dbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
NDA020699
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
75 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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
61919-920-302020-01-31C16284748780-19d75b9d0-20b9-f424-e053-dadaa90a57ceVENLAFAXINE HYDROCHLORIDE
61919-920-902020-01-31C16284748780-19d75b9d0-20b9-f424-e053-dadaa90a57ceVENLAFAXINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-920-30VENLAFAXINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE, DELAYED RELEASE303
61919-920-90VENLAFAXINE HYDROCHLORIDE90 in 1 BOTTLECAPSULE, DELAYED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-920-30EA - Each61919-9202489d34c-e27c-4ccc-a4f1-ef288bbb43a512015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [DIRECT RX]3
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [DIRECT RX]3
ETHYLCELLULOSE (100 MPA.S)INACTIVE INGREDIENT47MLB0F1MVVENLAFAXINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [DIRECT RX]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [DIRECT RX]3
GELATININACTIVE INGREDIENT2G86QN327LVENLAFAXINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [DIRECT RX]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6VENLAFAXINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [DIRECT RX]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVENLAFAXINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [DIRECT RX]3
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MVENLAFAXINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [DIRECT RX]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [DIRECT RX]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-920VENLAFAXINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [DIRECT RX]3Legacy NDC, 2 package rows20150811_2829937a-d59b-4abb-8873-0970cf4d38a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN2829937a-d59b-4abb-8873-0970cf4d38a13
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD2829937a-d59b-4abb-8873-0970cf4d38a13
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY2829937a-d59b-4abb-8873-0970cf4d38a13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-920-306191909203030 in 1 BOTTLEHistorical
61919-920-906191909209090 in 1 BOTTLEHistorical