Duloxetine

Product NDC
60760-759
11-digit product format
607600759
Labeler code
60760
Product ID
60760-759_39fa5490-f66d-79af-e063-6294a90a22ea
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
2017-03-16
Substance
DULOXETINE HYDROCHLORIDE
Active strength
20 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 HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596926

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60760-759-30Duloxetine30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-759-30EA - Each60760-759b0193136-df69-4a73-bb74-0fadc11c98a912025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN39fa4247-e864-f653-e063-6394a90ac98d1
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD39fa4247-e864-f653-e063-6394a90ac98d1
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY39fa4247-e864-f653-e063-6394a90ac98d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60760-759-306076007593030 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-759-30) 2025-07-15NoNoCurrent