FDA.reportPublic FDA data

Duloxetine

Product NDC
50090-6775
11-digit product format
500906775
Labeler code
50090
Product ID
50090-6775_81481944-52f6-4e1a-a841-c9a1a066e7d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090694
Marketing category
ANDA
Marketing start
2013-12-11
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Duloxetine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULOXETINE HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596934

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
50090-6775-0Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE3010
50090-6775-1Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6775-0EA - Each50090-6775da948f2f-7466-4e46-aed7-45d36f0c1edc12023-12-05
50090-6775-1EA - Each50090-6775a62f67d8-cd48-4512-b61e-3f1e260ab9f612023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6775DULOXETINE CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]8Current NDC, 2 package rows20240214_cdd870a9-3bed-42fc-b175-48aed5321969.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNcdd870a9-3bed-42fc-b175-48aed532196910
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDcdd870a9-3bed-42fc-b175-48aed532196910
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYcdd870a9-3bed-42fc-b175-48aed532196910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6775-05009067750030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6775-0) 2023-10-24NoNoHistorical
50090-6775-15009067750190 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6775-1) 2023-10-24NoNoHistorical