FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
21695-961
11-digit product format
216950961
Labeler code
21695
Product ID
21695-961_5fab494d-cda2-4307-af04-0ce5fce1b2f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA020699
Marketing category
NDA
Marketing start
2011-06-10
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
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
21695-961-302019-09-24C16284748780-1934fe258-4bf9-48b1-e053-8cdaa90a720aVenlafaxine hydrochloride Extended-Release Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-961-30Venlafaxine Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-961-30EA - Each21695-96109c6c84e-750f-4a09-89f7-3616a483837912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
ETHYLCELLULOSE (100 MPA.S)INACTIVE INGREDIENT47MLB0F1MVVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
GELATININACTIVE INGREDIENT2G86QN327LVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-961VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2Legacy NDC, 1 package rows20120223_2bb09fc1-1c0a-4586-9af9-5aed8d4322db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN2bb09fc1-1c0a-4586-9af9-5aed8d4322db2
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN2bb09fc1-1c0a-4586-9af9-5aed8d4322db2
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN2bb09fc1-1c0a-4586-9af9-5aed8d4322db2
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD2bb09fc1-1c0a-4586-9af9-5aed8d4322db2
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD2bb09fc1-1c0a-4586-9af9-5aed8d4322db2
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD2bb09fc1-1c0a-4586-9af9-5aed8d4322db2
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY2bb09fc1-1c0a-4586-9af9-5aed8d4322db2
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY2bb09fc1-1c0a-4586-9af9-5aed8d4322db2
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY2bb09fc1-1c0a-4586-9af9-5aed8d4322db2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-961-302169509613030 in 1 BOTTLE, PLASTICHistorical