FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
82804-038
11-digit product format
828040038
Labeler code
82804
Product ID
82804-038_5c558ab8-b4b3-4973-b016-ed5cfcb4d88b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA200834
Marketing category
ANDA
Marketing start
2011-11-23
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
150 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Venlafaxine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313581

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
82804-038-30Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
82804-038-60Venlafaxine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE601
82804-038-90Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-038-30EA - Each82804-038c0b4ec6c-00ec-4461-8a93-7896e896881a12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-038VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1Current NDC, 3 package rows20231109_5c558ab8-b4b3-4973-b016-ed5cfcb4d88b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN5c558ab8-b4b3-4973-b016-ed5cfcb4d88b1
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD5c558ab8-b4b3-4973-b016-ed5cfcb4d88b1
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY5c558ab8-b4b3-4973-b016-ed5cfcb4d88b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-038-308280400383030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (82804-038-30) 2023-11-07NoNoCurrent
82804-038-608280400386060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (82804-038-60) 2023-11-07NoNoCurrent
82804-038-908280400389090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (82804-038-90) 2023-11-07NoNoCurrent