FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
71335-1812
11-digit product format
713351812
Labeler code
71335
Product ID
71335-1812_f0bd21a3-bd51-44d0-afd8-a75b9129061f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212277
Marketing category
ANDA
Marketing start
2019-07-08
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
71335-1812-1Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE30103
71335-1812-2Venlafaxine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE60103
71335-1812-3Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE90103
71335-1812-4Venlafaxine Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE100103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1812VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 4 package rows20240915_1e1119f7-0c2e-4587-a24d-0066f73b2e65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN1e1119f7-0c2e-4587-a24d-0066f73b2e65103
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD1e1119f7-0c2e-4587-a24d-0066f73b2e65103
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY1e1119f7-0c2e-4587-a24d-0066f73b2e65103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1812-17133518120130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1812-1) 2021-06-220000-00-00NoNoCurrent
71335-1812-27133518120260 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1812-2) 2021-08-200000-00-00NoNoCurrent
71335-1812-37133518120390 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1812-3) 2021-03-180000-00-00NoNoCurrent
71335-1812-471335181204100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1812-4) 2024-09-060000-00-00NoNoCurrent