FDA.reportPublic FDA data

VENLAFAXINE

Product NDC
23155-247
11-digit product format
231550247
Labeler code
23155
Product ID
23155-247_c19d98d7-0180-40b2-97dd-507bb3f69327
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA078554
Marketing category
ANDA
Marketing start
2021-07-19
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VENLAFAXINE
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-247-01VENLAFAXINE100 in 1 BOTTLETABLET10022
23155-247-09VENLAFAXINE90 in 1 BOTTLETABLET9022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-247-01EA - Each23155-247d25495a1-fd3e-4bc9-9f08-a66e4576758c12013-02-13
23155-247-09EA - Each23155-247ae62aa2c-a487-42ee-9f32-b4cadc5aa0de12013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE TABLET [HERITAGE PHARMACEUTICALS INC.]8
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE TABLET [HERITAGE PHARMACEUTICALS INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE TABLET [HERITAGE PHARMACEUTICALS INC.]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VENLAFAXINE TABLET [HERITAGE PHARMACEUTICALS INC.]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8VENLAFAXINE TABLET [HERITAGE PHARMACEUTICALS INC.]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVENLAFAXINE TABLET [HERITAGE PHARMACEUTICALS INC.]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE TABLET [HERITAGE PHARMACEUTICALS INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VENLAFAXINE TABLET [HERITAGE PHARMACEUTICALS INC.]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVENLAFAXINE TABLET [HERITAGE PHARMACEUTICALS INC.]8
POVIDONEINACTIVE INGREDIENTFZ989GH94EVENLAFAXINE TABLET [HERITAGE PHARMACEUTICALS INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE TABLET [HERITAGE PHARMACEUTICALS INC.]8
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE TABLET [DIRECT RX]1
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE TABLET [DIRECT RX]1
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE HYDROCHLORIDE TABLET [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VENLAFAXINE HYDROCHLORIDE TABLET [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VENLAFAXINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8VENLAFAXINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8VENLAFAXINE HYDROCHLORIDE TABLET [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVENLAFAXINE HYDROCHLORIDE TABLET [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVENLAFAXINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE HYDROCHLORIDE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VENLAFAXINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VENLAFAXINE HYDROCHLORIDE TABLET [DIRECT RX]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVENLAFAXINE HYDROCHLORIDE TABLET [DIRECT RX]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVENLAFAXINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EVENLAFAXINE HYDROCHLORIDE TABLET [DIRECT RX]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EVENLAFAXINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE HYDROCHLORIDE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-247VENLAFAXINE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]21Current NDC, Legacy NDC, 2 package rows20231228_80ac757d-c629-4579-8afd-cae0ee9cd614.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313580venlafaxine HCl 100 MG Oral TabletPSN80ac757d-c629-4579-8afd-cae0ee9cd61422
313582venlafaxine HCl 25 MG Oral TabletPSN80ac757d-c629-4579-8afd-cae0ee9cd61422
313584venlafaxine HCl 37.5 MG Oral TabletPSN80ac757d-c629-4579-8afd-cae0ee9cd61422
314277venlafaxine HCl 50 MG Oral TabletPSN80ac757d-c629-4579-8afd-cae0ee9cd61422
313586venlafaxine HCl 75 MG Oral TabletPSN80ac757d-c629-4579-8afd-cae0ee9cd61422
313580venlafaxine 100 MG Oral TabletSCD80ac757d-c629-4579-8afd-cae0ee9cd61422
313582venlafaxine 25 MG Oral TabletSCD80ac757d-c629-4579-8afd-cae0ee9cd61422
313584venlafaxine 37.5 MG Oral TabletSCD80ac757d-c629-4579-8afd-cae0ee9cd61422
314277venlafaxine 50 MG Oral TabletSCD80ac757d-c629-4579-8afd-cae0ee9cd61422
313586venlafaxine 75 MG Oral TabletSCD80ac757d-c629-4579-8afd-cae0ee9cd61422
313580venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral TabletSY80ac757d-c629-4579-8afd-cae0ee9cd61422
313582venlafaxine 25 MG (as venlafaxine hydrochloride 28.3 MG) Oral TabletSY80ac757d-c629-4579-8afd-cae0ee9cd61422
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY80ac757d-c629-4579-8afd-cae0ee9cd61422
314277venlafaxine 50 MG (as venlafaxine hydrochloride 56.6 MG) Oral TabletSY80ac757d-c629-4579-8afd-cae0ee9cd61422
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY80ac757d-c629-4579-8afd-cae0ee9cd61422
313584venlafaxine HCl 37.5 MG Oral TabletPSN1756bedd-c8d7-434a-beb0-bb3c7bd3e5582
313584venlafaxine 37.5 MG Oral TabletSCD1756bedd-c8d7-434a-beb0-bb3c7bd3e5582
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY1756bedd-c8d7-434a-beb0-bb3c7bd3e5582
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-247-0123155024701100 TABLET in 1 BOTTLE (23155-247-01) 100 tablet2021-07-190000-00-00NoNoCurrent
23155-247-092315502470990 TABLET in 1 BOTTLE (23155-247-09) 90 tablet2021-07-190000-00-00NoNoCurrent