FDA.reportPublic FDA data

Venlafaxine hydrochloride

Product NDC
55111-549
11-digit product format
551110549
Labeler code
55111
Product ID
55111-549_20a19933-a7c1-3739-c472-272204375d1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA078301
Marketing category
ANDA
Marketing start
2008-06-16
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
100 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 hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE100 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
55111-549-01Venlafaxine hydrochloride100 in 1 BOTTLETABLET10013
55111-549-05Venlafaxine hydrochloride500 in 1 BOTTLETABLET50013
55111-549-30Venlafaxine hydrochloride30 in 1 BOTTLETABLET3013
55111-549-60Venlafaxine hydrochloride60 in 1 BOTTLETABLET6013
55111-549-79Venlafaxine hydrochloride10 in 1 BLISTER PACKTABLET1013
55111-549-79Venlafaxine hydrochloride1 in 1 CARTONTABLET113
55111-549-90Venlafaxine hydrochloride90 in 1 BOTTLETABLET9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-549-90EA - Each55111-54998d107c1-1b45-46cb-939b-332cee3244dd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Venlafaxine hydrochlorideACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]8
VenlafaxineACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVENLAFAXINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]8
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]8
magnesium stearateINACTIVE INGREDIENT70097M6I30VENLAFAXINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]8
povidoneINACTIVE INGREDIENTFZ989GH94EVENLAFAXINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2VENLAFAXINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-549VENLAFAXINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]13Current NDC, Legacy NDC, 7 package rows20221224_106d0d7b-925b-74e7-83cb-562144ce1f92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313580venlafaxine HCl 100 MG Oral TabletPSN106d0d7b-925b-74e7-83cb-562144ce1f9213
313582venlafaxine HCl 25 MG Oral TabletPSN106d0d7b-925b-74e7-83cb-562144ce1f9213
313584venlafaxine HCl 37.5 MG Oral TabletPSN106d0d7b-925b-74e7-83cb-562144ce1f9213
314277venlafaxine HCl 50 MG Oral TabletPSN106d0d7b-925b-74e7-83cb-562144ce1f9213
313586venlafaxine HCl 75 MG Oral TabletPSN106d0d7b-925b-74e7-83cb-562144ce1f9213
313580venlafaxine 100 MG Oral TabletSCD106d0d7b-925b-74e7-83cb-562144ce1f9213
313582venlafaxine 25 MG Oral TabletSCD106d0d7b-925b-74e7-83cb-562144ce1f9213
313584venlafaxine 37.5 MG Oral TabletSCD106d0d7b-925b-74e7-83cb-562144ce1f9213
314277venlafaxine 50 MG Oral TabletSCD106d0d7b-925b-74e7-83cb-562144ce1f9213
313586venlafaxine 75 MG Oral TabletSCD106d0d7b-925b-74e7-83cb-562144ce1f9213
313580venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral TabletSY106d0d7b-925b-74e7-83cb-562144ce1f9213
313582venlafaxine 25 MG (as venlafaxine hydrochloride 28.3 MG) Oral TabletSY106d0d7b-925b-74e7-83cb-562144ce1f9213
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY106d0d7b-925b-74e7-83cb-562144ce1f9213
314277venlafaxine 50 MG (as venlafaxine hydrochloride 56.6 MG) Oral TabletSY106d0d7b-925b-74e7-83cb-562144ce1f9213
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY106d0d7b-925b-74e7-83cb-562144ce1f9213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-549-0155111054901100 TABLET in 1 BOTTLE (55111-549-01) 100 tablet2008-06-160000-00-00NoNoCurrent
55111-549-0555111054905500 TABLET in 1 BOTTLE (55111-549-05) 500 tablet2008-06-160000-00-00NoNoCurrent
55111-549-305511105493030 TABLET in 1 BOTTLE (55111-549-30) 30 tablet2008-06-160000-00-00NoNoCurrent
55111-549-605511105496060 TABLET in 1 BOTTLE (55111-549-60) 60 tablet2008-06-160000-00-00NoNoCurrent
55111-549-79551110549791 BLISTER PACK in 1 CARTON (55111-549-79) / 10 TABLET in 1 BLISTER PACK1 blister pack2008-06-160000-00-00NoNoCurrent
55111-549-905511105499090 TABLET in 1 BOTTLE (55111-549-90) 90 tablet2008-06-160000-00-00NoNoCurrent