FDA.reportPublic FDA data

Venlafaxine HCL

Product NDC
80425-0194
11-digit product format
804250194
Labeler code
80425
Product ID
80425-0194_2a99c981-daf5-71e5-e063-6294a90a5c1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine HCL
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA212277
Marketing category
ANDA
Marketing start
2022-06-14
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 HCL
Brand name suffix
ER
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
80425-0194-2Venlafaxine HCLER60 in 1 BOTTLECAPSULE, EXTENDED RELEASE605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0194-2EA - Each80425-0194c36d847a-af66-4bef-bda5-1285658b80da12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0194VENLAFAXINE HCL ER (VENLAFAXINE HCL) CAPSULE, EXTENDED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]5Current NDC, Legacy NDC, 1 package rows20250101_d8e00b3d-29de-1de5-e053-2995a90acb51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNd8e00b3d-29de-1de5-e053-2995a90acb515
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDd8e00b3d-29de-1de5-e053-2995a90acb515
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYd8e00b3d-29de-1de5-e053-2995a90acb515

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0194-28042501940260 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0194-2) 2024-02-25NoNoHistorical