FDA.reportPublic FDA data

venlafaxine

Product NDC
68071-3433
11-digit product format
680713433
Labeler code
68071
Product ID
68071-3433_2d5887b5-8623-42a8-e063-6394a90a1b2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078932
Marketing category
ANDA
Marketing start
2015-10-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
venlafaxine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313580

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3433-02025-02-04C16284748780-12cef2736-6291-d83d-e063-dadaa90ab31fVenlafaxine Tablets, USP Rx only
68071-3433-02025-01-30C16284748780-12cef2736-6291-d83d-e063-dadaa90ab31fVenlafaxine Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3433-0venlafaxine100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3433VENLAFAXINE TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 1 package rows20250206_fda14f3f-b32c-42fe-e053-6294a90a103f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313580venlafaxine HCl 100 MG Oral TabletPSNfda14f3f-b32c-42fe-e053-6294a90a103f2
313580venlafaxine 100 MG Oral TabletSCDfda14f3f-b32c-42fe-e053-6294a90a103f2
313580venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral TabletSYfda14f3f-b32c-42fe-e053-6294a90a103f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3433-068071343300100 TABLET in 1 BOTTLE (68071-3433-0) 100 tablet2023-06-08NoNoCurrent