FDA.reportPublic FDA data

venlafaxine hydrochloride

Product NDC
55111-454
11-digit product format
551110454
Labeler code
55111
Product ID
55111-454_a0b75dbc-2382-70bc-7bd9-c6ef3ee4ed3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Dr.Reddy's Laboratories Ltd.
Application
ANDA078421
Marketing category
ANDA
Marketing start
2011-06-01
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 hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313581, 313583, 313585

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
55111-454-01venlafaxine hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1008
55111-454-05venlafaxine hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5008
55111-454-30venlafaxine hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE308
55111-454-60venlafaxine hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE608
55111-454-78venlafaxine hydrochloride10 in 1 CARTONCAPSULE, EXTENDED RELEASE108
55111-454-79venlafaxine hydrochloride10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE108
55111-454-90venlafaxine hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-454-05EA - Each55111-454f612eb89-6291-4d10-8050-0d0fbf07c5c512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]6
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]6
AMMONIAINACTIVE INGREDIENT5138Q19F1XVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]6
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERINACTIVE INGREDIENT905HNO1SIHVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]6
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]6
gelatinINACTIVE INGREDIENT2G86QN327LVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]6
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]6
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]6
POVIDONEINACTIVE INGREDIENTFZ989GH94EVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]6
SHELLACINACTIVE INGREDIENT46N107B71OVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]6
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]6
talcINACTIVE INGREDIENT7SEV7J4R1UVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]6
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-454VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]8Current NDC, Legacy NDC, 7 package rows20181207_7027be98-61d6-a986-c9df-60ceef5f7ff0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN7027be98-61d6-a986-c9df-60ceef5f7ff08
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN7027be98-61d6-a986-c9df-60ceef5f7ff08
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN7027be98-61d6-a986-c9df-60ceef5f7ff08
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD7027be98-61d6-a986-c9df-60ceef5f7ff08
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD7027be98-61d6-a986-c9df-60ceef5f7ff08
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD7027be98-61d6-a986-c9df-60ceef5f7ff08
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY7027be98-61d6-a986-c9df-60ceef5f7ff08
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY7027be98-61d6-a986-c9df-60ceef5f7ff08
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY7027be98-61d6-a986-c9df-60ceef5f7ff08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-454-0155111045401100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55111-454-01) 2011-06-010000-00-00NoNoCurrent
55111-454-0555111045405500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55111-454-05) 2011-06-010000-00-00NoNoCurrent
55111-454-305511104543030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55111-454-30) 2011-06-010000-00-00NoNoCurrent
55111-454-605511104546060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55111-454-60) 2011-06-010000-00-00NoNoCurrent
55111-454-785511104547810 BLISTER PACK in 1 CARTON (55111-454-78) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (55111-454-79) 10 blister pack2011-06-010000-00-00NoNoCurrent
55111-454-795511104547910 in 1 BLISTER PACKHistorical
55111-454-905511104549090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55111-454-90) 2011-06-010000-00-00NoNoCurrent