FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
50090-6834
11-digit product format
500906834
Labeler code
50090
Product ID
50090-6834_6a4b8ce0-260c-43ce-9dad-49df32bcb274
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA214654
Marketing category
ANDA
Marketing start
2022-09-07
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
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 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
50090-6834-0Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303
50090-6834-1Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6834-0EA - Each50090-68347da02cd9-d03f-4e38-a7fc-ba15cf29364412023-12-05
50090-6834-1EA - Each50090-68344a750d7e-d9d7-4c5e-8240-fea173dbd5fb12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6834VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20231128_5a990dbd-f280-4caf-b950-4703ee98b230.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN5a990dbd-f280-4caf-b950-4703ee98b2303
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD5a990dbd-f280-4caf-b950-4703ee98b2303
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY5a990dbd-f280-4caf-b950-4703ee98b2303

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6834-05009068340030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-6834-0) 2023-11-21NoNoHistorical
50090-6834-15009068340190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-6834-1) 2023-11-21NoNoHistorical