FDA.reportPublic FDA data

Duloxetine

Product NDC
50090-6889
11-digit product format
500906889
Labeler code
50090
Product ID
50090-6889_2bcd10f1-d5c6-4886-ac10-39e7a658448d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203088
Marketing category
ANDA
Marketing start
2014-06-11
Substance
DULOXETINE HYDROCHLORIDE
Active strength
20 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
Brand name suffix
Delayed-Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULOXETINE HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596926

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
50090-6889-0Duloxetine Delayed-Release90 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS905
50090-6889-1Duloxetine Delayed-Release30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6889-0EA - Each50090-6889a5128851-8241-444d-bb5c-df9334b8b3b612024-01-04
50090-6889-1EA - Each50090-6889bbcc274e-b936-461e-970c-54119ee5bfa012024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6889DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [A-S MEDICATION SOLUTIONS]5Current NDC, 2 package rows20240612_be33f3cb-6fd1-4377-816e-84bd49370e9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSNbe33f3cb-6fd1-4377-816e-84bd49370e9e5
596926duloxetine 20 MG Delayed Release Oral CapsuleSCDbe33f3cb-6fd1-4377-816e-84bd49370e9e5
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSYbe33f3cb-6fd1-4377-816e-84bd49370e9e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6889-05009068890090 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (50090-6889-0) 2023-12-06NoNoCurrent
50090-6889-15009068890130 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (50090-6889-1) 2023-12-06NoNoCurrent