FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
68788-8072
11-digit product format
687888072
Labeler code
68788
Product ID
68788-8072_219c816d-9278-43e0-9a27-9f39cabee426
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA212277
Marketing category
ANDA
Marketing start
2021-08-27
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
68788-8072-3Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE305
68788-8072-6Venlafaxine Hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5005
68788-8072-9Venlafaxine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8072-3EA - Each68788-807273da0a5f-269b-4acb-9af9-b6ca4bd86f7e12021-10-08
68788-8072-6EA - Each68788-80725fe4b87e-9537-4726-8abe-6452117207a412021-10-08
68788-8072-9EA - Each68788-80721d334915-d5d5-451c-bd55-ef1ea69f7e4b12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8072VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 3 package rows20240901_b18d726e-cdb2-4c80-a49d-330cddee17e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNb18d726e-cdb2-4c80-a49d-330cddee17e95
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDb18d726e-cdb2-4c80-a49d-330cddee17e95
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYb18d726e-cdb2-4c80-a49d-330cddee17e95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8072-36878880720330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8072-3) 2021-08-270000-00-00NoNoCurrent
68788-8072-668788807206500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8072-6) 2021-08-270000-00-00NoNoCurrent
68788-8072-96878880720960 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8072-9) 2021-08-270000-00-00NoNoCurrent