FDA.reportPublic FDA data

venlafaxine hydrochloride

Product NDC
65841-753
11-digit product format
658410753
Labeler code
65841
Product ID
65841-753_f20749dc-d1f6-4860-b583-82b82d3a2242
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA090174
Marketing category
ANDA
Marketing start
2011-06-01
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
150 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 HYDROCHLORIDE150 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65841-753-06venlafaxine hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3010
65841-753-10venlafaxine hydrochloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE100010
65841-753-16venlafaxine hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9010

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)INACTIVE INGREDIENTP2OM2Q86BIVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
GELATININACTIVE INGREDIENT2G86QN327LVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
TALCINACTIVE INGREDIENT7SEV7J4R1UVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-753VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]10Current NDC, Legacy NDC, 3 package rows20231005_1be1be3a-304b-4e31-8732-335247029191.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN1be1be3a-304b-4e31-8732-33524702919110
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN1be1be3a-304b-4e31-8732-33524702919110
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN1be1be3a-304b-4e31-8732-33524702919110
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD1be1be3a-304b-4e31-8732-33524702919110
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD1be1be3a-304b-4e31-8732-33524702919110
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD1be1be3a-304b-4e31-8732-33524702919110
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY1be1be3a-304b-4e31-8732-33524702919110
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY1be1be3a-304b-4e31-8732-33524702919110
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY1be1be3a-304b-4e31-8732-33524702919110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65841-753-066584107530630 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65841-753-06) 2011-06-010000-00-00NoNoCurrent
65841-753-10658410753101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65841-753-10) 2011-06-010000-00-00NoNoCurrent
65841-753-166584107531690 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65841-753-16) 2011-06-010000-00-00NoNoCurrent