FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
0615-8510
11-digit product format
006158510
Labeler code
0615
Product ID
0615-8510_f4c48a47-b134-4ed0-a838-0af90d59dc5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA217390
Marketing category
ANDA
Marketing start
2023-09-25
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, 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8510-39Venlafaxine Hydrochloride30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8510VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]1Current NDC, 1 package rows20240620_9c061460-3b80-41e1-a87a-1a25108ff740.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN9c061460-3b80-41e1-a87a-1a25108ff7401
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN9c061460-3b80-41e1-a87a-1a25108ff7401
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD9c061460-3b80-41e1-a87a-1a25108ff7401
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD9c061460-3b80-41e1-a87a-1a25108ff7401
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY9c061460-3b80-41e1-a87a-1a25108ff7401
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY9c061460-3b80-41e1-a87a-1a25108ff7401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0615-8510-390061585103930 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0615-8510-39) 2024-05-16NoNoCurrent