FDA.reportPublic FDA data

Venlafaxine

Product NDC
43598-944
11-digit product format
435980944
Labeler code
43598
Product ID
43598-944_79d34297-6604-4031-a89a-8ec557d078d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA214609
Marketing category
ANDA
Marketing start
2021-09-20
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
225 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE225 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui808744, 808748

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
43598-944-30Venlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE304
43598-944-90Venlafaxine90 in 1 BOTTLETABLET, EXTENDED RELEASE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-944-30EA - Each43598-9443917eb6c-22d6-4e52-8949-2968171a50fc12021-12-08
43598-944-90EA - Each43598-944f10fc2c7-69c1-41d8-bc39-20bc0b15596c12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-944VENLAFAXINE TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC.]4Current NDC, Legacy NDC, 2 package rows20240130_9312f4df-63d9-4167-880f-36a816870442.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808744venlafaxine HCl 150 MG 24HR Extended Release Oral TabletPSN9312f4df-63d9-4167-880f-36a8168704424
808748venlafaxine HCl 225 MG 24HR Extended Release Oral TabletPSN9312f4df-63d9-4167-880f-36a8168704424
80874424 HR venlafaxine 150 MG Extended Release Oral TabletSCD9312f4df-63d9-4167-880f-36a8168704424
80874824 HR venlafaxine 225 MG Extended Release Oral TabletSCD9312f4df-63d9-4167-880f-36a8168704424
808744venlafaxine 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY9312f4df-63d9-4167-880f-36a8168704424
808744venlafaxine 150 MG 24 HR Extended Release Oral TabletSY9312f4df-63d9-4167-880f-36a8168704424
808748venlafaxine 225 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY9312f4df-63d9-4167-880f-36a8168704424
808748venlafaxine 225 MG 24 HR Extended Release Oral TabletSY9312f4df-63d9-4167-880f-36a8168704424

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-944-304359809443030 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-944-30) 2021-09-200000-00-00NoNoCurrent
43598-944-904359809449090 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-944-90) 2021-09-200000-00-00NoNoCurrent