FDA.reportPublic FDA data

venlafaxine

Product NDC
46708-431
11-digit product format
467080431
Labeler code
46708
Product ID
46708-431_47576e3f-2b6d-4334-8733-748687e5b784
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA078932
Marketing category
ANDA
Marketing start
2015-10-01
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
37.5 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 HYDROCHLORIDE37.5 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46708-431-302023-02-01C16284748780-1f386c649-dc18-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP Rx only
46708-431-312023-02-01C16284748780-1f386c649-dc18-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP Rx only
46708-431-912023-02-01C16284748780-1f386c649-dc18-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP Rx only
46708-431-302023-01-30C16284748780-1f386c649-dc18-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP Rx only
46708-431-312023-01-30C16284748780-1f386c649-dc18-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP Rx only
46708-431-912023-01-30C16284748780-1f386c649-dc18-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-431-30venlafaxine30 in 1 BOTTLETABLET303
46708-431-31venlafaxine100 in 1 BOTTLETABLET1003
46708-431-91venlafaxine1000 in 1 BOTTLETABLET10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-431VENLAFAXINE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]3Current NDC, Legacy NDC, 3 package rows20230202_b73da6e2-1494-436f-a204-2e4e4c5974b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313580venlafaxine HCl 100 MG Oral TabletPSNb73da6e2-1494-436f-a204-2e4e4c5974b63
313582venlafaxine HCl 25 MG Oral TabletPSNb73da6e2-1494-436f-a204-2e4e4c5974b63
313584venlafaxine HCl 37.5 MG Oral TabletPSNb73da6e2-1494-436f-a204-2e4e4c5974b63
314277venlafaxine HCl 50 MG Oral TabletPSNb73da6e2-1494-436f-a204-2e4e4c5974b63
313586venlafaxine HCl 75 MG Oral TabletPSNb73da6e2-1494-436f-a204-2e4e4c5974b63
313580venlafaxine 100 MG Oral TabletSCDb73da6e2-1494-436f-a204-2e4e4c5974b63
313582venlafaxine 25 MG Oral TabletSCDb73da6e2-1494-436f-a204-2e4e4c5974b63
313584venlafaxine 37.5 MG Oral TabletSCDb73da6e2-1494-436f-a204-2e4e4c5974b63
314277venlafaxine 50 MG Oral TabletSCDb73da6e2-1494-436f-a204-2e4e4c5974b63
313586venlafaxine 75 MG Oral TabletSCDb73da6e2-1494-436f-a204-2e4e4c5974b63
313580venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral TabletSYb73da6e2-1494-436f-a204-2e4e4c5974b63
313582venlafaxine 25 MG (as venlafaxine hydrochloride 28.3 MG) Oral TabletSYb73da6e2-1494-436f-a204-2e4e4c5974b63
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSYb73da6e2-1494-436f-a204-2e4e4c5974b63
314277venlafaxine 50 MG (as venlafaxine hydrochloride 56.6 MG) Oral TabletSYb73da6e2-1494-436f-a204-2e4e4c5974b63
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSYb73da6e2-1494-436f-a204-2e4e4c5974b63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-431-304670804313030 TABLET in 1 BOTTLE (46708-431-30) 30 tablet2015-10-010000-00-00NoNoCurrent
46708-431-3146708043131100 TABLET in 1 BOTTLE (46708-431-31) 100 tablet2015-10-010000-00-00NoNoCurrent
46708-431-91467080431911000 TABLET in 1 BOTTLE (46708-431-91) 1000 tablet2015-10-010000-00-00NoNoCurrent