FDA.reportPublic FDA data

Venlafaxine

Product NDC
68001-159
11-digit product format
680010159
Labeler code
68001
Product ID
68001-159_04c5d11d-d249-eb93-e063-6294a90a1b46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine
Dosage form
TABLET
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA077653
Marketing category
ANDA
Marketing start
2013-11-25
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
50 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 HYDROCHLORIDE50 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
68001-159-00Venlafaxine100 in 1 BOTTLETABLET10014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-159-00EA - Each68001-159eb43820d-8941-45a8-ae2c-87282fdbeea612014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE TABLET [BLUEPOINT LABORATORIES]5
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE TABLET [BLUEPOINT LABORATORIES]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE TABLET [BLUEPOINT LABORATORIES]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE TABLET [BLUEPOINT LABORATORIES]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVENLAFAXINE TABLET [BLUEPOINT LABORATORIES]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE TABLET [BLUEPOINT LABORATORIES]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VENLAFAXINE TABLET [BLUEPOINT LABORATORIES]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2VENLAFAXINE TABLET [BLUEPOINT LABORATORIES]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-159VENLAFAXINE TABLET [BLUEPOINT LABORATORIES]14Current NDC, Legacy NDC, 1 package rows20230908_172b3d3d-bdae-47bf-8fba-edd6da1a8649.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313580venlafaxine HCl 100 MG Oral TabletPSN172b3d3d-bdae-47bf-8fba-edd6da1a864914
313582venlafaxine HCl 25 MG Oral TabletPSN172b3d3d-bdae-47bf-8fba-edd6da1a864914
313584venlafaxine HCl 37.5 MG Oral TabletPSN172b3d3d-bdae-47bf-8fba-edd6da1a864914
314277venlafaxine HCl 50 MG Oral TabletPSN172b3d3d-bdae-47bf-8fba-edd6da1a864914
313586venlafaxine HCl 75 MG Oral TabletPSN172b3d3d-bdae-47bf-8fba-edd6da1a864914
313580venlafaxine 100 MG Oral TabletSCD172b3d3d-bdae-47bf-8fba-edd6da1a864914
313582venlafaxine 25 MG Oral TabletSCD172b3d3d-bdae-47bf-8fba-edd6da1a864914
313584venlafaxine 37.5 MG Oral TabletSCD172b3d3d-bdae-47bf-8fba-edd6da1a864914
314277venlafaxine 50 MG Oral TabletSCD172b3d3d-bdae-47bf-8fba-edd6da1a864914
313586venlafaxine 75 MG Oral TabletSCD172b3d3d-bdae-47bf-8fba-edd6da1a864914
313580venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral TabletSY172b3d3d-bdae-47bf-8fba-edd6da1a864914
313582venlafaxine 25 MG (as venlafaxine hydrochloride 28.3 MG) Oral TabletSY172b3d3d-bdae-47bf-8fba-edd6da1a864914
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY172b3d3d-bdae-47bf-8fba-edd6da1a864914
314277venlafaxine 50 MG (as venlafaxine hydrochloride 56.6 MG) Oral TabletSY172b3d3d-bdae-47bf-8fba-edd6da1a864914
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY172b3d3d-bdae-47bf-8fba-edd6da1a864914
314277venlafaxine HCl 50 MG Oral TabletPSN26bb33c9-0e36-56f4-e063-6394a90a8d411
314277venlafaxine 50 MG Oral TabletSCD26bb33c9-0e36-56f4-e063-6394a90a8d411
314277venlafaxine 50 MG (as venlafaxine hydrochloride 56.6 MG) Oral TabletSY26bb33c9-0e36-56f4-e063-6394a90a8d411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-159-0068001015900100 TABLET in 1 BOTTLE (68001-159-00) 100 tablet2013-11-250000-00-00NoNoCurrent