FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
50090-2281
11-digit product format
500902281
Labeler code
50090
Product ID
50090-2281_2fe060da-94be-4852-9986-f2cfebde33ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA200834
Marketing category
ANDA
Marketing start
2011-06-01
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
37.5 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Venlafaxine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313581, 313583, 313585

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
50090-2281-02023-02-07C16284748780-1f386c649-b81b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1997
50090-2281-12023-02-07C16284748780-1f386c649-b81b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1997
50090-2281-02023-01-30C16284748780-1f386c649-b81b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1997
50090-2281-12023-01-30C16284748780-1f386c649-b81b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2281-0Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3033
50090-2281-1Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2281-0EA - Each50090-228182dd91f5-ad14-4b46-903a-4a4e381b77b312019-02-13
50090-2281-1EA - Each50090-22816692287f-db0c-48e6-8f58-d78a5f3cf0c912019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2281VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]30Current NDC, Legacy NDC, 2 package rows20230608_7852be9e-0c1d-47a8-9513-c3a04b365763.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN7852be9e-0c1d-47a8-9513-c3a04b36576333
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN7852be9e-0c1d-47a8-9513-c3a04b36576333
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN7852be9e-0c1d-47a8-9513-c3a04b36576333
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD7852be9e-0c1d-47a8-9513-c3a04b36576333
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD7852be9e-0c1d-47a8-9513-c3a04b36576333
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD7852be9e-0c1d-47a8-9513-c3a04b36576333
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY7852be9e-0c1d-47a8-9513-c3a04b36576333
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY7852be9e-0c1d-47a8-9513-c3a04b36576333
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY7852be9e-0c1d-47a8-9513-c3a04b36576333

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2281-05009022810030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-2281-0) 2015-12-310000-00-00NoNoCurrent
50090-2281-15009022810190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-2281-1) 2018-03-090000-00-00NoNoCurrent