Duloxetine

Product NDC
60687-745
11-digit product format
606870745
Labeler code
60687
Product ID
60687-745_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
2023-04-20
Marketing end
2026-05-31
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
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
60687-745-01Duloxetine100 in 1 CARTONCAPSULE, DELAYED RELEASE1004
60687-745-11Duloxetine1 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-745-01EA - Each60687-7450d8b86fd-d706-4865-8730-36bc3b31188112023-03-13
60687-745-11EA - Each60687-745b6540ad2-62be-4f05-a85a-0b1188be439412023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-745DULOXETINE (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
60687-745-0160687074501100 BLISTER PACK in 1 CARTON (60687-745-01) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (60687-745-11) 100 blister pack2023-04-202026-05-31NoNoHistorical
60687-745-11606870745111 in 1 BLISTER PACKHistorical