Venlafaxine Hydrochloride

Product NDC
69367-417
11-digit product format
693670417
Labeler code
69367
Product ID
69367-417_f5372620-d970-4c76-b148-35264d890c1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA205468
Marketing category
ANDA
Marketing start
2025-11-18
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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE150 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
69367-417-09Venlafaxine Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE901
69367-417-30Venlafaxine Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-417-09EA - Each69367-41780d6fc02-81a9-4b5c-bf92-85133e86e9ed12026-02-05
69367-417-30EA - Each69367-4172f1941fb-4607-4a97-9e20-0163c6569b8b12026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808744venlafaxine HCl 150 MG 24HR Extended Release Oral TabletPSN349308ef-2caf-4fec-b428-56ae06c6771d1
808748venlafaxine HCl 225 MG 24HR Extended Release Oral TabletPSN349308ef-2caf-4fec-b428-56ae06c6771d1
80874424 HR venlafaxine 150 MG Extended Release Oral TabletSCD349308ef-2caf-4fec-b428-56ae06c6771d1
80874824 HR venlafaxine 225 MG Extended Release Oral TabletSCD349308ef-2caf-4fec-b428-56ae06c6771d1
808744venlafaxine 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY349308ef-2caf-4fec-b428-56ae06c6771d1
808744venlafaxine 150 MG 24 HR Extended Release Oral TabletSY349308ef-2caf-4fec-b428-56ae06c6771d1
808748venlafaxine 225 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY349308ef-2caf-4fec-b428-56ae06c6771d1
808748venlafaxine 225 MG 24 HR Extended Release Oral TabletSY349308ef-2caf-4fec-b428-56ae06c6771d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69367-417-096936704170990 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-417-09) 2025-11-18NoNoCurrent
69367-417-306936704173030 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-417-30) 2025-11-18NoNoCurrent