FDA.reportPublic FDA data

Duloxetine

Product NDC
63187-666
11-digit product format
631870666
Labeler code
63187
Product ID
63187-666_516a73f5-d543-4c59-9281-cf7b5a6dd2bf
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
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
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
63187-666-30Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE303
63187-666-60Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE603
63187-666-90Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-666-30EA - Each63187-666afe09d5f-c89a-41e5-ae60-8be561ff3ab612016-06-14
63187-666-60EA - Each63187-6662f19a90f-604a-4d1b-b2c1-cfa11e4cff0312016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-666DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20210112_51c342c9-b9c6-467d-8fea-b73d72e3febc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN51c342c9-b9c6-467d-8fea-b73d72e3febc3
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD51c342c9-b9c6-467d-8fea-b73d72e3febc3
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY51c342c9-b9c6-467d-8fea-b73d72e3febc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-666-306318706663030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-666-30) 2018-12-010000-00-00NoNoCurrent
63187-666-606318706666060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-666-60) 2018-12-010000-00-00NoNoCurrent
63187-666-906318706669090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-666-90) 2018-12-010000-00-00NoNoCurrent