Duloxetine

Product NDC
60687-723
11-digit product format
606870723
Labeler code
60687
Product ID
60687-723_3140ed8f-e974-d45b-e063-6294a90a725d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine Hydrochloride
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA090778
Marketing category
ANDA
Marketing start
2023-04-25
Marketing end
2026-05-31
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
Current FDA listing
Yes

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
60687-723-11Duloxetine1 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE14
60687-723-21Duloxetine30 in 1 CARTONCAPSULE, DELAYED RELEASE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-723-11EA - Each60687-72382750397-0bbb-42ff-9d12-859abc0c341212023-05-05
60687-723-21EA - Each60687-723820b92be-9af2-4109-958b-f4bd3c19a95012023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-723DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4Current NDC, 2 package rows20250328_7da3d2c4-8793-4da3-b54a-ae20717cf066.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-723-11606870723111 in 1 BLISTER PACKHistorical
60687-723-216068707232130 BLISTER PACK in 1 CARTON (60687-723-21) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (60687-723-11) 30 blister pack2023-04-252026-05-31NoNoHistorical