FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
71335-1642
11-digit product format
713351642
Labeler code
71335
Product ID
71335-1642_d3841153-2586-4128-bbef-6af24cedd1d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1642-1Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE305
71335-1642-2Venlafaxine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE605
71335-1642-3Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE905
71335-1642-4Venlafaxine Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1642-1EA - Each71335-16429aa350d6-e0ec-44cb-9b8e-8540689f3b2d12022-02-07
71335-1642-2EA - Each71335-1642bfaf3742-3c33-48db-9d32-693fc149f3c812023-12-05
71335-1642-3EA - Each71335-16428a69e023-85f9-451b-9f27-8bf29d0fa90f12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1642VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 4 package rows20240602_04340ccb-c3b3-41ab-a4bc-101d8b6bc1a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN04340ccb-c3b3-41ab-a4bc-101d8b6bc1a95
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD04340ccb-c3b3-41ab-a4bc-101d8b6bc1a95
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY04340ccb-c3b3-41ab-a4bc-101d8b6bc1a95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1642-17133516420130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1642-1) 2020-06-160000-00-00NoNoCurrent
71335-1642-27133516420260 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1642-2) 2020-06-080000-00-00NoNoCurrent
71335-1642-37133516420390 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1642-3) 2020-08-170000-00-00NoNoCurrent
71335-1642-471335164204100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1642-4) 2020-10-210000-00-00NoNoCurrent