FDA.reportPublic FDA data

Venlafaxine

Product NDC
63629-3324
11-digit product format
636293324
Labeler code
63629
Product ID
63629-3324_8835dd5f-f15f-46e0-bc19-079933018cd2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077653
Marketing category
ANDA
Marketing start
2008-06-13
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
75 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 HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313586

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
63629-3324-1Venlafaxine60 in 1 BOTTLETABLET6012
63629-3324-2Venlafaxine30 in 1 BOTTLETABLET3012
63629-3324-3Venlafaxine90 in 1 BOTTLETABLET9012
63629-3324-4Venlafaxine28 in 1 BOTTLETABLET2812
63629-3324-5Venlafaxine120 in 1 BOTTLETABLET12012
63629-3324-6Venlafaxine100 in 1 BOTTLETABLET10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3324-1EA - Each63629-3324a0becbef-c719-45a7-bce9-b6ed9b71763a12012-07-24
63629-3324-2EA - Each63629-3324092fae7a-9a56-4e2c-b78c-57330fb7b01712012-07-24
63629-3324-3EA - Each63629-3324b137bf61-4f87-4f50-a452-e648b958dac912012-07-24
63629-3324-4EA - Each63629-332452361df6-9f00-4074-8475-88fbfcbbde9712015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVENLAFAXINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VENLAFAXINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2VENLAFAXINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-3324VENLAFAXINE TABLET [BRYANT RANCH PREPACK]12Current NDC, Legacy NDC, 6 package rows20240830_185d90ab-1ba4-dd59-0565-e35f0fd39a2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313586venlafaxine HCl 75 MG Oral TabletPSN185d90ab-1ba4-dd59-0565-e35f0fd39a2d12
313586venlafaxine 75 MG Oral TabletSCD185d90ab-1ba4-dd59-0565-e35f0fd39a2d12
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY185d90ab-1ba4-dd59-0565-e35f0fd39a2d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-3324-16362933240160 TABLET in 1 BOTTLE (63629-3324-1) 60 tablet2023-03-030000-00-00NoNoCurrent
63629-3324-26362933240230 TABLET in 1 BOTTLE (63629-3324-2) 30 tablet2009-02-160000-00-00NoNoCurrent
63629-3324-36362933240390 TABLET in 1 BOTTLE (63629-3324-3) 90 tablet2010-02-030000-00-00NoNoCurrent
63629-3324-46362933240428 TABLET in 1 BOTTLE (63629-3324-4) 28 tablet2012-02-020000-00-00NoNoCurrent
63629-3324-563629332405120 TABLET in 1 BOTTLE (63629-3324-5) 120 tablet2014-02-270000-00-00NoNoCurrent
63629-3324-663629332406100 TABLET in 1 BOTTLE (63629-3324-6) 100 tablet2016-03-040000-00-00NoNoCurrent