FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
50090-5942
11-digit product format
500905942
Labeler code
50090
Product ID
50090-5942_01f5a844-b38f-43ca-ad85-e0806cc94aba
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
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
50090-5942-0Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE307
50090-5942-1Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5942-0EA - Each50090-59425c7460e6-cc2b-4c96-8098-365214ea9ba412022-07-06
50090-5942-1EA - Each50090-5942bd10f36a-b7fd-4373-95f1-481c68c7ca7212022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5942VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 2 package rows20230723_52319578-f7cc-4b87-b532-f341854e40b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN52319578-f7cc-4b87-b532-f341854e40b47
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD52319578-f7cc-4b87-b532-f341854e40b47
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY52319578-f7cc-4b87-b532-f341854e40b47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5942-05009059420030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5942-0) 2022-03-170000-00-00NoNoCurrent
50090-5942-15009059420190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5942-1) 2022-07-050000-00-00NoNoCurrent