FDA.reportPublic FDA data

Duloxetine

Product NDC
50090-6899
11-digit product format
500906899
Labeler code
50090
Product ID
50090-6899_6305eb2c-9868-4672-8df2-2ac727f8c5d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208706
Marketing category
ANDA
Marketing start
2017-03-16
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
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
50090-6899-0Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE304
50090-6899-1Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6899-0EA - Each50090-68990eac2d07-5cb6-4947-b0e1-865928e83e1512024-02-14
50090-6899-1EA - Each50090-689996671359-901d-49b6-9b17-c391100e6a2612024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6899DULOXETINE CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]4Current NDC, 2 package rows20231216_b6040e79-0bbd-41a3-ba86-2a360a41864c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNb6040e79-0bbd-41a3-ba86-2a360a41864c4
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDb6040e79-0bbd-41a3-ba86-2a360a41864c4
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYb6040e79-0bbd-41a3-ba86-2a360a41864c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6899-05009068990030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6899-0) 2023-12-11NoNoCurrent
50090-6899-15009068990190 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6899-1) 2023-12-11NoNoCurrent