FDA.reportPublic FDA data

Venlafaxine

Product NDC
67877-728
11-digit product format
678770728
Labeler code
67877
Product ID
67877-728_17943f8a-6ea6-4e86-93cc-df580774a8d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA214127
Marketing category
ANDA
Marketing start
2021-06-11
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui808744, 808748, 808751, 808753

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-728-30Venlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE3011
67877-728-90Venlafaxine90 in 1 BOTTLETABLET, EXTENDED RELEASE9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-728-30EA - Each67877-72887cbb3cc-fb63-45d1-a6b8-c954d08fa20212021-08-05
67877-728-90EA - Each67877-728c2c49e55-5664-40d6-b064-e5cc64035ef612022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-728VENLAFAXINE TABLET, EXTENDED RELEASE [ASCEND LABORATORIES, LLC]11Current NDC, Legacy NDC, 2 package rows20240730_528d5392-4ad5-48c5-963d-6ebfb9187db4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808744venlafaxine HCl 150 MG 24HR Extended Release Oral TabletPSN528d5392-4ad5-48c5-963d-6ebfb9187db411
808748venlafaxine HCl 225 MG 24HR Extended Release Oral TabletPSN528d5392-4ad5-48c5-963d-6ebfb9187db411
808751venlafaxine HCl 37.5 MG 24HR Extended Release Oral TabletPSN528d5392-4ad5-48c5-963d-6ebfb9187db411
808753venlafaxine HCl 75 MG 24HR Extended Release Oral TabletPSN528d5392-4ad5-48c5-963d-6ebfb9187db411
80874424 HR venlafaxine 150 MG Extended Release Oral TabletSCD528d5392-4ad5-48c5-963d-6ebfb9187db411
80874824 HR venlafaxine 225 MG Extended Release Oral TabletSCD528d5392-4ad5-48c5-963d-6ebfb9187db411
80875124 HR venlafaxine 37.5 MG Extended Release Oral TabletSCD528d5392-4ad5-48c5-963d-6ebfb9187db411
80875324 HR venlafaxine 75 MG Extended Release Oral TabletSCD528d5392-4ad5-48c5-963d-6ebfb9187db411
808744venlafaxine 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY528d5392-4ad5-48c5-963d-6ebfb9187db411
808744venlafaxine 150 MG 24 HR Extended Release Oral TabletSY528d5392-4ad5-48c5-963d-6ebfb9187db411
808748venlafaxine 225 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY528d5392-4ad5-48c5-963d-6ebfb9187db411
808748venlafaxine 225 MG 24 HR Extended Release Oral TabletSY528d5392-4ad5-48c5-963d-6ebfb9187db411
808751venlafaxine 37.5 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY528d5392-4ad5-48c5-963d-6ebfb9187db411
808751venlafaxine 37.5 MG 24 HR Extended Release Oral TabletSY528d5392-4ad5-48c5-963d-6ebfb9187db411
808753venlafaxine 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY528d5392-4ad5-48c5-963d-6ebfb9187db411
808753venlafaxine 75 MG 24 HR Extended Release Oral TabletSY528d5392-4ad5-48c5-963d-6ebfb9187db411
808744venlafaxine HCl 150 MG 24HR Extended Release Oral TabletPSN4b23e4bd-b6ab-42f2-b389-0be0b7e11b921
80874424 HR venlafaxine 150 MG Extended Release Oral TabletSCD4b23e4bd-b6ab-42f2-b389-0be0b7e11b921
808744venlafaxine 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY4b23e4bd-b6ab-42f2-b389-0be0b7e11b921
808744venlafaxine 150 MG 24 HR Extended Release Oral TabletSY4b23e4bd-b6ab-42f2-b389-0be0b7e11b921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67877-728-306787707283030 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-728-30) 2021-06-110000-00-00NoNoCurrent
67877-728-906787707289090 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-728-90) 2021-06-110000-00-00NoNoCurrent