FDA.reportPublic FDA data

venlafaxine hydrochloride

Product NDC
50090-6301
11-digit product format
500906301
Labeler code
50090
Product ID
50090-6301_a374bf84-105a-4f9d-8303-2b27df2e7bff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090174
Marketing category
ANDA
Marketing start
2011-06-01
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
Rxcui313583

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
50090-6301-0venlafaxine hydrochloride1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE14
50090-6301-0venlafaxine hydrochloride33 in 1 CARTONCAPSULE, EXTENDED RELEASE334

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6301-0EA - Each50090-630102a81f15-009f-4790-a3a3-413045ab790012023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6301VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 2 package rows20230106_8d6e699b-24bf-4e77-8a7f-acd496a700c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN8d6e699b-24bf-4e77-8a7f-acd496a700c74
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD8d6e699b-24bf-4e77-8a7f-acd496a700c74
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY8d6e699b-24bf-4e77-8a7f-acd496a700c74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6301-05009063010033 BLISTER PACK in 1 CARTON (50090-6301-0) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK33 blister pack2022-12-290000-00-00NoNoCurrent