FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
64980-581
11-digit product format
649800581
Labeler code
64980
Product ID
64980-581_7f187899-ddc6-4e15-b2af-e54f59d5baf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA216044
Marketing category
ANDA
Marketing start
2022-11-28
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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE225 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
64980-581-03Venlafaxine Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE303
64980-581-09Venlafaxine Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-581-03EA - Each64980-58161301164-91e6-4f65-ae1e-127dcacce59f12023-09-05
64980-581-09EA - Each64980-58158ec5a28-6a02-4243-84c7-6e754982b90012023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-581VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE ) TABLET, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.]2Current NDC, 2 package rows20231227_074f4478-e81b-45a2-ae85-ffd27bed940f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808744venlafaxine HCl 150 MG 24HR Extended Release Oral TabletPSN074f4478-e81b-45a2-ae85-ffd27bed940f3
808748venlafaxine HCl 225 MG 24HR Extended Release Oral TabletPSN074f4478-e81b-45a2-ae85-ffd27bed940f3
808751venlafaxine HCl 37.5 MG 24HR Extended Release Oral TabletPSN074f4478-e81b-45a2-ae85-ffd27bed940f3
808753venlafaxine HCl 75 MG 24HR Extended Release Oral TabletPSN074f4478-e81b-45a2-ae85-ffd27bed940f3
80874424 HR venlafaxine 150 MG Extended Release Oral TabletSCD074f4478-e81b-45a2-ae85-ffd27bed940f3
80874824 HR venlafaxine 225 MG Extended Release Oral TabletSCD074f4478-e81b-45a2-ae85-ffd27bed940f3
80875124 HR venlafaxine 37.5 MG Extended Release Oral TabletSCD074f4478-e81b-45a2-ae85-ffd27bed940f3
80875324 HR venlafaxine 75 MG Extended Release Oral TabletSCD074f4478-e81b-45a2-ae85-ffd27bed940f3
808744venlafaxine 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY074f4478-e81b-45a2-ae85-ffd27bed940f3
808744venlafaxine 150 MG 24 HR Extended Release Oral TabletSY074f4478-e81b-45a2-ae85-ffd27bed940f3
808748venlafaxine 225 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY074f4478-e81b-45a2-ae85-ffd27bed940f3
808748venlafaxine 225 MG 24 HR Extended Release Oral TabletSY074f4478-e81b-45a2-ae85-ffd27bed940f3
808751venlafaxine 37.5 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY074f4478-e81b-45a2-ae85-ffd27bed940f3
808751venlafaxine 37.5 MG 24 HR Extended Release Oral TabletSY074f4478-e81b-45a2-ae85-ffd27bed940f3
808753venlafaxine 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY074f4478-e81b-45a2-ae85-ffd27bed940f3
808753venlafaxine 75 MG 24 HR Extended Release Oral TabletSY074f4478-e81b-45a2-ae85-ffd27bed940f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
64980-581-036498005810330 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-581-03) 2022-11-28NoNoCurrent
64980-581-096498005810990 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-581-09) 2022-11-28NoNoCurrent