FDA.reportPublic FDA data

Duloxetine HCL

Product NDC
80425-0086
11-digit product format
804250086
Labeler code
80425
Product ID
80425-0086_2a98f01a-8da4-0770-e063-6294a90a7bab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine HCL
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA090776
Marketing category
ANDA
Marketing start
2013-12-17
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
80425-0086-1Duloxetine HCLDR30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS308
80425-0086-2Duloxetine HCLDR60 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0086-1EA - Each80425-0086102f4941-252e-4913-9548-2e4635b2794d12023-04-07
80425-0086-2EA - Each80425-00868b2a3537-4838-4173-a964-1e4ee15359c012023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0086DULOXETINE HCL DR (DULOXETINE HCL) CAPSULE, DELAYED RELEASE PELLETS [ADVANCED RX OF TENNESSEE, LLC]8Current NDC, Legacy NDC, 2 package rows20250101_b33cbab8-1962-cb66-e053-2a95a90a4ae7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNb33cbab8-1962-cb66-e053-2a95a90a4ae78
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDb33cbab8-1962-cb66-e053-2a95a90a4ae78
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYb33cbab8-1962-cb66-e053-2a95a90a4ae78

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0086-18042500860130 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (80425-0086-1) 2013-12-170000-00-00NoNoCurrent
80425-0086-28042500860260 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (80425-0086-2) 2013-12-170000-00-00NoNoCurrent