FDA.reportPublic FDA data

DULOXETINE

Product NDC
43547-381
11-digit product format
435470381
Labeler code
43547
Product ID
43547-381_1b037cb5-9db9-44a6-89dd-1cf1dcf895fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA206653
Marketing category
ANDA
Marketing start
2016-01-20
Substance
DULOXETINE HYDROCHLORIDE
Active strength
60 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULOXETINE HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596926, 596930, 596934

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-381-03DULOXETINE30 in 1 BOTTLECAPSULE, DELAYED RELEASE3010
43547-381-09DULOXETINE90 in 1 BOTTLECAPSULE, DELAYED RELEASE9010
43547-381-11DULOXETINE1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-381DULOXETINE CAPSULE, DELAYED RELEASE [SOLCO HEALTHCARE US, LLC]10Current NDC, Legacy NDC, 3 package rows20230715_a105a648-6a97-4151-b9de-d7eac90a8f79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSNa105a648-6a97-4151-b9de-d7eac90a8f7910
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNa105a648-6a97-4151-b9de-d7eac90a8f7910
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNa105a648-6a97-4151-b9de-d7eac90a8f7910
596926duloxetine 20 MG Delayed Release Oral CapsuleSCDa105a648-6a97-4151-b9de-d7eac90a8f7910
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDa105a648-6a97-4151-b9de-d7eac90a8f7910
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDa105a648-6a97-4151-b9de-d7eac90a8f7910
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSYa105a648-6a97-4151-b9de-d7eac90a8f7910
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYa105a648-6a97-4151-b9de-d7eac90a8f7910
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYa105a648-6a97-4151-b9de-d7eac90a8f7910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-381-034354703810330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-381-03) 2016-01-200000-00-00NoNoCurrent
43547-381-094354703810990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-381-09) 2016-01-200000-00-00NoNoCurrent
43547-381-11435470381111000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-381-11) 2016-01-200000-00-00NoNoCurrent