FDA.reportPublic FDA data

venlafaxine hydrochloride

Product NDC
62135-531
11-digit product format
621350531
Labeler code
62135
Product ID
62135-531_45adb66f-add1-678a-e063-6394a90a1f26
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA209193
Marketing category
ANDA
Marketing start
2019-12-26
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
Rxcui808748

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
62135-531-30venlafaxine hydrochloride30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-531-30EA - Each62135-5315581df41-7299-4c3d-8ed2-169892420b7212023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-531VENLAFAXINE HYDROCHLORIDE TABLET [CHARTWELL RX, LLC]1Current NDC, 1 package rows20230401_85ec2d3f-49e4-4ac5-bd4a-c227589dbf58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808748venlafaxine HCl 225 MG 24HR Extended Release Oral TabletPSN85ec2d3f-49e4-4ac5-bd4a-c227589dbf582
80874824 HR venlafaxine 225 MG Extended Release Oral TabletSCD85ec2d3f-49e4-4ac5-bd4a-c227589dbf582
808748venlafaxine 225 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY85ec2d3f-49e4-4ac5-bd4a-c227589dbf582
808748venlafaxine 225 MG 24 HR Extended Release Oral TabletSY85ec2d3f-49e4-4ac5-bd4a-c227589dbf582

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-531-306213505313030 TABLET in 1 BOTTLE (62135-531-30) 30 tablet2023-03-29NoNoHistorical