FDA.reportPublic FDA data

Duloxetine

Product NDC
63187-612
11-digit product format
631870612
Labeler code
63187
Product ID
63187-612_9e0aea8e-e493-432d-a390-5f6d7944ba69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine Hydrochloride
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090778
Marketing category
ANDA
Marketing start
2013-12-11
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
63187-612-30Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE303
63187-612-60Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE603
63187-612-90Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-612-30EA - Each63187-61218b64109-bdef-4807-876d-a6f04cec500112016-04-04
63187-612-60EA - Each63187-61295426210-5b17-4bab-89bc-729ed14cda8012016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-612DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20210113_c34f6115-f447-450f-8c83-58f3c51a76c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNc34f6115-f447-450f-8c83-58f3c51a76c93
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDc34f6115-f447-450f-8c83-58f3c51a76c93
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYc34f6115-f447-450f-8c83-58f3c51a76c93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-612-306318706123030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-612-30) 2018-12-010000-00-00NoNoCurrent
63187-612-606318706126060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-612-60) 2018-12-010000-00-00NoNoCurrent
63187-612-906318706129090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-612-90) 2018-12-010000-00-00NoNoCurrent