FDA.reportPublic FDA data

venlafaxine

Product NDC
62332-008
11-digit product format
623320008
Labeler code
62332
Product ID
62332-008_8724b94d-b3fd-4844-a7fe-2be7982cf8f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA078932
Marketing category
ANDA
Marketing start
2015-10-01
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 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
62332-008-30venlafaxine30 in 1 BOTTLETABLET3016
62332-008-31venlafaxine100 in 1 BOTTLETABLET10016
62332-008-91venlafaxine1000 in 1 BOTTLETABLET100016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-008-31EA - Each62332-0080f055c4e-a6f1-4eca-8a58-895b62db66ea12016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE TABLET [ALEMBIC PHARMACEUTICALS INC.]4
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE TABLET [ALEMBIC PHARMACEUTICALS INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE TABLET [ALEMBIC PHARMACEUTICALS INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVENLAFAXINE TABLET [ALEMBIC PHARMACEUTICALS INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE TABLET [ALEMBIC PHARMACEUTICALS INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVENLAFAXINE TABLET [ALEMBIC PHARMACEUTICALS INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE TABLET [ALEMBIC PHARMACEUTICALS INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VENLAFAXINE TABLET [ALEMBIC PHARMACEUTICALS INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-008VENLAFAXINE TABLET [ALEMBIC PHARMACEUTICALS INC.]16Current NDC, Legacy NDC, 3 package rows20230928_67b323a7-a8c9-410f-bff0-0e515bef41a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313580venlafaxine HCl 100 MG Oral TabletPSN67b323a7-a8c9-410f-bff0-0e515bef41a716
313582venlafaxine HCl 25 MG Oral TabletPSN67b323a7-a8c9-410f-bff0-0e515bef41a716
313584venlafaxine HCl 37.5 MG Oral TabletPSN67b323a7-a8c9-410f-bff0-0e515bef41a716
314277venlafaxine HCl 50 MG Oral TabletPSN67b323a7-a8c9-410f-bff0-0e515bef41a716
313586venlafaxine HCl 75 MG Oral TabletPSN67b323a7-a8c9-410f-bff0-0e515bef41a716
313580venlafaxine 100 MG Oral TabletSCD67b323a7-a8c9-410f-bff0-0e515bef41a716
313582venlafaxine 25 MG Oral TabletSCD67b323a7-a8c9-410f-bff0-0e515bef41a716
313584venlafaxine 37.5 MG Oral TabletSCD67b323a7-a8c9-410f-bff0-0e515bef41a716
314277venlafaxine 50 MG Oral TabletSCD67b323a7-a8c9-410f-bff0-0e515bef41a716
313586venlafaxine 75 MG Oral TabletSCD67b323a7-a8c9-410f-bff0-0e515bef41a716
313580venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral TabletSY67b323a7-a8c9-410f-bff0-0e515bef41a716
313582venlafaxine 25 MG (as venlafaxine hydrochloride 28.3 MG) Oral TabletSY67b323a7-a8c9-410f-bff0-0e515bef41a716
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY67b323a7-a8c9-410f-bff0-0e515bef41a716
314277venlafaxine 50 MG (as venlafaxine hydrochloride 56.6 MG) Oral TabletSY67b323a7-a8c9-410f-bff0-0e515bef41a716
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY67b323a7-a8c9-410f-bff0-0e515bef41a716
313582venlafaxine HCl 25 MG Oral TabletPSN5c2e417d-8f09-4efc-86bf-d822c0471a901
313582venlafaxine HCl 25 MG Oral TabletPSN470ad045-6c82-4e44-8e88-0e2b01a41ff21
313582venlafaxine 25 MG Oral TabletSCD5c2e417d-8f09-4efc-86bf-d822c0471a901
313582venlafaxine 25 MG Oral TabletSCD470ad045-6c82-4e44-8e88-0e2b01a41ff21
313582venlafaxine 25 MG (as venlafaxine hydrochloride 28.3 MG) Oral TabletSY470ad045-6c82-4e44-8e88-0e2b01a41ff21
313582venlafaxine 25 MG (as venlafaxine hydrochloride 28.3 MG) Oral TabletSY5c2e417d-8f09-4efc-86bf-d822c0471a901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-008-306233200083030 TABLET in 1 BOTTLE (62332-008-30) 30 tablet2015-10-010000-00-00NoNoCurrent
62332-008-3162332000831100 TABLET in 1 BOTTLE (62332-008-31) 100 tablet2015-10-010000-00-00NoNoCurrent
62332-008-91623320008911000 TABLET in 1 BOTTLE (62332-008-91) 1000 tablet2015-10-010000-00-00NoNoCurrent