FDA.reportPublic FDA data

venlafaxine hydrochloride, extended release

Product NDC
42799-963
11-digit product format
427990963
Labeler code
42799
Product ID
42799-963_a7958920-40c7-4038-8524-3f830555d345
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride, extended release
Dosage form
TABLET
Route
ORAL
Labeler
Edenbridge Pharmaceuticals LLC.
Application
ANDA209193
Marketing category
ANDA
Marketing start
2023-03-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
venlafaxine hydrochloride, extended release
Listing expiration
2027-12-31

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
42799-963-01venlafaxine hydrochloride, extended release30 in 1 BOTTLETABLET304
42799-963-02venlafaxine hydrochloride, extended release90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42799-963VENLAFAXINE HYDROCHLORIDE, EXTENDED RELEASE TABLET [EDENBRIDGE PHARMACEUTICALS LLC.]3Current NDC, 2 package rows20240105_38431a76-6185-4c17-994f-8278b6cd7510.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808744venlafaxine HCl 150 MG 24HR Extended Release Oral TabletPSN38431a76-6185-4c17-994f-8278b6cd75104
808748venlafaxine HCl 225 MG 24HR Extended Release Oral TabletPSN38431a76-6185-4c17-994f-8278b6cd75104
80874424 HR venlafaxine 150 MG Extended Release Oral TabletSCD38431a76-6185-4c17-994f-8278b6cd75104
80874824 HR venlafaxine 225 MG Extended Release Oral TabletSCD38431a76-6185-4c17-994f-8278b6cd75104
808744venlafaxine 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY38431a76-6185-4c17-994f-8278b6cd75104
808744venlafaxine 150 MG 24 HR Extended Release Oral TabletSY38431a76-6185-4c17-994f-8278b6cd75104
808748venlafaxine 225 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY38431a76-6185-4c17-994f-8278b6cd75104
808748venlafaxine 225 MG 24 HR Extended Release Oral TabletSY38431a76-6185-4c17-994f-8278b6cd75104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42799-963-014279909630130 TABLET in 1 BOTTLE (42799-963-01) 30 tablet2023-03-15NoNoCurrent
42799-963-024279909630290 TABLET in 1 BOTTLE (42799-963-02) 90 tablet2023-03-15NoNoCurrent