FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
50090-5890
11-digit product format
500905890
Labeler code
50090
Product ID
50090-5890_708bf3c0-c834-43cc-9fab-d22a0615ffc9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA212277
Marketing category
ANDA
Marketing start
2019-07-08
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

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
50090-5890-0Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303
50090-5890-1Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5890-0EA - Each50090-589074a9883b-c7eb-4eff-99bb-46fe84e7b38812022-06-06
50090-5890-1EA - Each50090-58903315afb7-c3c6-4bb6-b5bc-f48d7fc6841f12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5890VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 2 package rows20231125_df7e0982-3eb0-4bdf-8f7f-4f4a48476ed7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNdf7e0982-3eb0-4bdf-8f7f-4f4a48476ed73
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDdf7e0982-3eb0-4bdf-8f7f-4f4a48476ed73
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYdf7e0982-3eb0-4bdf-8f7f-4f4a48476ed73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5890-05009058900030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5890-0) 2022-01-100000-00-00NoNoCurrent
50090-5890-15009058900190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5890-1) 2022-01-100000-00-00NoNoCurrent