FDA.reportPublic FDA data

Duloxetine HCL

Product NDC
80425-0146
11-digit product format
804250146
Labeler code
80425
Product ID
80425-0146_2a999573-1035-813a-e063-6294a90a49b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine HCL
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA208706
Marketing category
ANDA
Marketing start
2017-03-16
Substance
DULOXETINE HYDROCHLORIDE
Active strength
30 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
Duloxetine HCL
Brand name suffix
DR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULOXETINE HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596930

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0146-1Duloxetine HCLDR30 in 1 BOTTLECAPSULE, DELAYED RELEASE309
80425-0146-2Duloxetine HCLDR60 in 1 BOTTLECAPSULE, DELAYED RELEASE609
80425-0146-3Duloxetine HCLDR90 in 1 BOTTLECAPSULE, DELAYED RELEASE909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0146-1EA - Each80425-01463c472cb1-ec7d-4cd2-95f2-5fcd67ca178612023-06-06
80425-0146-2EA - Each80425-0146574073d7-581d-4d39-befa-18705d96487712023-06-06
80425-0146-3EA - Each80425-0146d2406371-2b40-4cdf-8c91-8c85a09eb3f012023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0146DULOXETINE HCL DR (DULOXETINE HCL) CAPSULE, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]9Current NDC, Legacy NDC, 3 package rows20250101_c4fa1d3b-f136-e14f-e053-2a95a90a6cfb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNc4fa1d3b-f136-e14f-e053-2a95a90a6cfb9
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDc4fa1d3b-f136-e14f-e053-2a95a90a6cfb9
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYc4fa1d3b-f136-e14f-e053-2a95a90a6cfb9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0146-18042501460130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0146-1) 2023-06-14NoNoHistorical
80425-0146-28042501460260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0146-2) 2023-06-14NoNoHistorical
80425-0146-38042501460390 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0146-3) 2023-06-14NoNoHistorical