Duloxetine

Product NDC
31722-582
11-digit product format
317220582
Labeler code
31722
Product ID
31722-582_74de48c9-1785-40b1-b55f-e3bc1641f8d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA204343
Marketing category
ANDA
Marketing start
2016-08-11
Marketing end
0000-00-00
Substance
DULOXETINE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-582-30EA - Each31722-5824618e9ec-d3f2-4f7e-b6dc-293b6a90853712016-10-06
31722-582-90EA - Each31722-582fa7ae592-33af-48ac-8e6d-ad638422d78812016-10-06

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN0ba5b758-5dd4-4d65-9952-1f80ae9d195e4
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD0ba5b758-5dd4-4d65-9952-1f80ae9d195e4
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY0ba5b758-5dd4-4d65-9952-1f80ae9d195e4
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNbcd11524-8111-5c7f-e053-2995a90a457a2
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDbcd11524-8111-5c7f-e053-2995a90a457a2
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYbcd11524-8111-5c7f-e053-2995a90a457a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-582-0131722058201100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-582-01) 2016-08-110000-00-00NoNoCurrent
31722-582-303172205823030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-582-30) 2016-08-110000-00-00NoNoCurrent
31722-582-31317220582317 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (31722-582-31) 2016-08-110000-00-00NoNoCurrent
31722-582-3231722058232105 CAPSULE, DELAYED RELEASE in 1 CARTON (31722-582-32) 2016-08-110000-00-00NoNoCurrent
31722-582-903172205829090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-582-90) 2016-08-110000-00-00NoNoCurrent