FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
71335-2779
11-digit product format
713352779
Labeler code
71335
Product ID
71335-2779_d62baf0c-d78e-42b3-9739-93cb3dcafc53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA217390
Marketing category
ANDA
Marketing start
2023-09-25
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
37.5 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Venlafaxine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313583

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
71335-2779-1Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302
71335-2779-2Venlafaxine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE602
71335-2779-3Venlafaxine Hydrochloride10 in 1 BOTTLECAPSULE, EXTENDED RELEASE102
71335-2779-4Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE902
71335-2779-5Venlafaxine Hydrochloride14 in 1 BOTTLECAPSULE, EXTENDED RELEASE142

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN7aa3edba-4248-49bb-86f7-06fdbf2a6fb72
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD7aa3edba-4248-49bb-86f7-06fdbf2a6fb72
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY7aa3edba-4248-49bb-86f7-06fdbf2a6fb72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2779-17133527790130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2779-1) 2025-10-13NoNoHistorical
71335-2779-27133527790260 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2779-2) 2025-10-13NoNoHistorical
71335-2779-37133527790310 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2779-3) 2025-10-13NoNoHistorical
71335-2779-47133527790490 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2779-4) 2025-10-13NoNoHistorical
71335-2779-57133527790514 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2779-5) 2025-10-13NoNoHistorical