FDA.reportPublic FDA data

Duloxetine HCL

Product NDC
80425-0014
11-digit product format
804250014
Labeler code
80425
Product ID
80425-0014_2a985779-9478-6d0e-e063-6294a90aa2a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine HCL
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA090778
Marketing category
ANDA
Marketing start
2022-12-11
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
80425-0014-1Duloxetine HCLDR30 in 1 BOTTLECAPSULE, DELAYED RELEASE307
80425-0014-2Duloxetine HCLDR60 in 1 BOTTLECAPSULE, DELAYED RELEASE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0014-1EA - Each80425-001401f13271-03ce-4cfd-8bf4-e972ec84ee7d12023-04-07
80425-0014-2EA - Each80425-0014a797dd86-ceea-406e-9882-5e5257c5e90212023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0014DULOXETINE HCL DR (DULOXETINE HCL) CAPSULE, DELAYED RELEASE [ADVANCED RX OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 2 package rows20250101_afd59273-75cb-5f33-e053-2995a90ab25f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNafd59273-75cb-5f33-e053-2995a90ab25f7
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDafd59273-75cb-5f33-e053-2995a90ab25f7
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYafd59273-75cb-5f33-e053-2995a90ab25f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0014-18042500140130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0014-1) 2022-12-110000-00-00NoNoCurrent
80425-0014-28042500140260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0014-2) 2022-12-110000-00-00NoNoCurrent