FDA.reportPublic FDA data

venlafaxine hydrochloride

Product NDC
71335-1338
11-digit product format
713351338
Labeler code
71335
Product ID
71335-1338_570cf492-91f5-4377-b8ee-8502012cd1a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090174
Marketing category
ANDA
Marketing start
2011-06-01
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
75 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 HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313585

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
71335-1338-1venlafaxine hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE90101
71335-1338-2venlafaxine hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE60101
71335-1338-3venlafaxine hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE30101
71335-1338-4venlafaxine hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE100101
71335-1338-5venlafaxine hydrochloride7 in 1 BOTTLECAPSULE, EXTENDED RELEASE7101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1338VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 5 package rows20230331_f02cc6e8-186f-46e8-9675-70fd55d002c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNf02cc6e8-186f-46e8-9675-70fd55d002c4101
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDf02cc6e8-186f-46e8-9675-70fd55d002c4101
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYf02cc6e8-186f-46e8-9675-70fd55d002c4101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1338-17133513380190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1338-1) 2022-02-090000-00-00NoNoCurrent
71335-1338-27133513380260 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1338-2) 2022-02-090000-00-00NoNoCurrent
71335-1338-37133513380330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1338-3) 2022-02-090000-00-00NoNoCurrent
71335-1338-471335133804100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1338-4) 2022-02-090000-00-00NoNoCurrent
71335-1338-5713351338057 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1338-5) 2022-02-090000-00-00NoNoCurrent