FDA.reportPublic FDA data

VENLAFAXINE HYDROCHLORIDE

Product NDC
10135-825
11-digit product format
101350825
Labeler code
10135
Product ID
10135-825_3d59e057-318b-f098-e063-6394a90a25be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Marlex Pharmaceuticals, Inc.
Application
ANDA201272
Marketing category
ANDA
Marketing start
2025-08-01
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
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 HYDROCHLORIDE37.5 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
10135-825-10VENLAFAXINE HYDROCHLORIDE1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10002
10135-825-30VENLAFAXINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302
10135-825-75VENLAFAXINE HYDROCHLORIDE15 in 1 BOTTLECAPSULE, EXTENDED RELEASE152
10135-825-90VENLAFAXINE HYDROCHLORIDE90 in 1 BOTTLECAPSULE, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-825-10EA - Each10135-825b46207d4-64ce-4480-8f3e-12fd89e0004112025-10-14
10135-825-30EA - Each10135-82564f3c097-d100-4ec6-91d4-327a0c05cc9712025-10-14
10135-825-90EA - Each10135-825db2102cc-cd42-498c-b0ec-603e823da68812025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN3c2e188f-76aa-a022-e063-6294a90abfc92
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN3c2e188f-76aa-a022-e063-6294a90abfc92
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN3c2e188f-76aa-a022-e063-6294a90abfc92
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD3c2e188f-76aa-a022-e063-6294a90abfc92
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD3c2e188f-76aa-a022-e063-6294a90abfc92
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD3c2e188f-76aa-a022-e063-6294a90abfc92
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY3c2e188f-76aa-a022-e063-6294a90abfc92
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY3c2e188f-76aa-a022-e063-6294a90abfc92
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY3c2e188f-76aa-a022-e063-6294a90abfc92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
10135-825-10101350825101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-825-10) 2025-08-01NoNoCurrent
10135-825-301013508253030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-825-30) 2025-08-01NoNoCurrent
10135-825-751013508257515 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-825-75) 2025-08-01NoNoCurrent
10135-825-901013508259090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-825-90) 2025-08-01NoNoCurrent