FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
71205-408
11-digit product format
712050408
Labeler code
71205
Product ID
71205-408_6ae4c40d-f4c1-4ba8-8299-b2527edeff1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA200834
Marketing category
ANDA
Marketing start
2011-06-01
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
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 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
71205-408-30Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302
71205-408-60Venlafaxine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE602
71205-408-90Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-408-30EA - Each71205-408cd2237d3-2b1d-4556-905c-e376d4b5d19712020-04-20
71205-408-60EA - Each71205-4083a2c16d1-c90e-4abc-a626-22621af7113412022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-408VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220710_aaa14e95-904e-45c6-be4d-c94167b20300.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNaaa14e95-904e-45c6-be4d-c94167b203002
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDaaa14e95-904e-45c6-be4d-c94167b203002
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYaaa14e95-904e-45c6-be4d-c94167b203002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-408-307120504083030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-408-30) 2020-02-210000-00-00NoNoCurrent
71205-408-607120504086060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-408-60) 2020-02-210000-00-00NoNoCurrent
71205-408-907120504089090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-408-90) 2020-02-210000-00-00NoNoCurrent