FDA.reportPublic FDA data

Duloxetine

Product NDC
60760-461
11-digit product format
607600461
Labeler code
60760
Product ID
60760-461_45745bf3-a131-b51a-e063-6394a90a712e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA208706
Marketing category
ANDA
Marketing start
2019-09-05
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
60760-461-30Duloxetine30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE307
60760-461-60Duloxetine60 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-461-30EA - Each60760-46187fe6487-c1a4-4a3c-a07b-8d978fd46f4812019-10-07
60760-461-60EA - Each60760-46154cd8d0c-553e-4202-8cac-d675b0eb542b12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-461DULOXETINE CAPSULE, DELAYED RELEASE [ST. MARY'S MEDICAL PARK PHARMACY]6Current NDC, Legacy NDC, 2 package rows20240616_9221aea1-8de1-b94e-e053-2a95a90a1eae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN9221aea1-8de1-b94e-e053-2a95a90a1eae7
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD9221aea1-8de1-b94e-e053-2a95a90a1eae7
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY9221aea1-8de1-b94e-e053-2a95a90a1eae7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-461-306076004613030 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-461-30) 2019-09-050000-00-00NoNoCurrent
60760-461-606076004616060 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-461-60) 2019-10-210000-00-00NoNoCurrent