FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
70518-4280
11-digit product format
705184280
Labeler code
70518
Product ID
70518-4280_48813dbe-f3e1-6f7a-e063-6294a90af176
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA212277
Marketing category
ANDA
Marketing start
2025-02-07
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313585

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
70518-4280-0Venlafaxine Hydrochloride30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE303
70518-4280-1Venlafaxine Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4280VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.]1Current NDC, 2 package rows20250210_c41d847b-88ba-49a5-9d73-269ac4caa4ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNc41d847b-88ba-49a5-9d73-269ac4caa4ed3
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDc41d847b-88ba-49a5-9d73-269ac4caa4ed3
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYc41d847b-88ba-49a5-9d73-269ac4caa4ed3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4280-07051842800030 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-4280-0) 2025-02-07NoNoHistorical
70518-4280-17051842800190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4280-1) 2026-01-15NoNoHistorical