Venlafaxine

Product NDC
33261-677
11-digit product format
332610677
Labeler code
33261
Product ID
33261-677_e4ca368f-2ead-4dd5-bdfb-53644b99e8c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078554
Marketing category
ANDA
Marketing start
2012-11-30
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
38 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
33261-677-302020-01-31C16284748780-19d75b9d0-fa51-f424-e053-dadaa90a57ceVenlafaxine Tablets, USP
33261-677-602020-01-31C16284748780-19d75b9d0-fa51-f424-e053-dadaa90a57ceVenlafaxine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-677-30Venlafaxine30 in 1 BOTTLE, PLASTICTABLET301
33261-677-60Venlafaxine60 in 1 BOTTLE, PLASTICTABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-677-30EA - Each33261-6772dd038f6-2f50-4065-80b3-81162c2ad21512015-10-02
33261-677-60EA - Each33261-677d5bf4684-41e4-4924-a6b8-db4203e4325f12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VENLAFAXINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8VENLAFAXINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVENLAFAXINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VENLAFAXINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVENLAFAXINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EVENLAFAXINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-677VENLAFAXINE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20140213_4902b757-1387-4dc4-a685-ad5af29fe8c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313584venlafaxine HCl 37.5 MG Oral TabletPSN4902b757-1387-4dc4-a685-ad5af29fe8c21
313586venlafaxine HCl 75 MG Oral TabletPSN4902b757-1387-4dc4-a685-ad5af29fe8c21
313584venlafaxine 37.5 MG Oral TabletSCD4902b757-1387-4dc4-a685-ad5af29fe8c21
313586venlafaxine 75 MG Oral TabletSCD4902b757-1387-4dc4-a685-ad5af29fe8c21
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY4902b757-1387-4dc4-a685-ad5af29fe8c21
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY4902b757-1387-4dc4-a685-ad5af29fe8c21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-677-303326106773030 in 1 BOTTLE, PLASTICHistorical
33261-677-603326106776060 in 1 BOTTLE, PLASTICHistorical