FDA.reportPublic FDA data

VENLAFAXINE

Product NDC
23155-250
11-digit product format
231550250
Labeler code
23155
Product ID
23155-250_c19d98d7-0180-40b2-97dd-507bb3f69327
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA078554
Marketing category
ANDA
Marketing start
2021-07-19
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
100 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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313580, 313582, 313584, 313586, 314277

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
23155-250-01VENLAFAXINE100 in 1 BOTTLETABLET10022
23155-250-09VENLAFAXINE90 in 1 BOTTLETABLET9022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-250VENLAFAXINE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]21Current NDC, Legacy NDC, 2 package rows20231228_80ac757d-c629-4579-8afd-cae0ee9cd614.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313580venlafaxine HCl 100 MG Oral TabletPSN80ac757d-c629-4579-8afd-cae0ee9cd61422
313582venlafaxine HCl 25 MG Oral TabletPSN80ac757d-c629-4579-8afd-cae0ee9cd61422
313584venlafaxine HCl 37.5 MG Oral TabletPSN80ac757d-c629-4579-8afd-cae0ee9cd61422
314277venlafaxine HCl 50 MG Oral TabletPSN80ac757d-c629-4579-8afd-cae0ee9cd61422
313586venlafaxine HCl 75 MG Oral TabletPSN80ac757d-c629-4579-8afd-cae0ee9cd61422
313580venlafaxine 100 MG Oral TabletSCD80ac757d-c629-4579-8afd-cae0ee9cd61422
313582venlafaxine 25 MG Oral TabletSCD80ac757d-c629-4579-8afd-cae0ee9cd61422
313584venlafaxine 37.5 MG Oral TabletSCD80ac757d-c629-4579-8afd-cae0ee9cd61422
314277venlafaxine 50 MG Oral TabletSCD80ac757d-c629-4579-8afd-cae0ee9cd61422
313586venlafaxine 75 MG Oral TabletSCD80ac757d-c629-4579-8afd-cae0ee9cd61422
313580venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral TabletSY80ac757d-c629-4579-8afd-cae0ee9cd61422
313582venlafaxine 25 MG (as venlafaxine hydrochloride 28.3 MG) Oral TabletSY80ac757d-c629-4579-8afd-cae0ee9cd61422
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY80ac757d-c629-4579-8afd-cae0ee9cd61422
314277venlafaxine 50 MG (as venlafaxine hydrochloride 56.6 MG) Oral TabletSY80ac757d-c629-4579-8afd-cae0ee9cd61422
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY80ac757d-c629-4579-8afd-cae0ee9cd61422

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-250-0123155025001100 TABLET in 1 BOTTLE (23155-250-01) 100 tablet2021-07-192027-06-30NoNoCurrent
23155-250-092315502500990 TABLET in 1 BOTTLE (23155-250-09) 90 tablet2021-07-190000-00-00NoNoCurrent