Duloxetine

Product NDC
31722-581
11-digit product format
317220581
Labeler code
31722
Product ID
31722-581_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
20 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
31722-581-60EA - Each31722-5812a3714be-fd5f-4b8e-a8ef-20ab65e9911412016-10-06

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN0500c320-2954-46a0-9437-091753f56bab1
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD0500c320-2954-46a0-9437-091753f56bab1
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY0500c320-2954-46a0-9437-091753f56bab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-581-0131722058101100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-581-01) 2016-08-110000-00-00NoNoCurrent
31722-581-303172205813030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-581-30) 2016-08-110000-00-00NoNoCurrent
31722-581-31317220581317 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (31722-581-31) 2016-08-110000-00-00NoNoCurrent
31722-581-3231722058132105 CAPSULE, DELAYED RELEASE in 1 CARTON (31722-581-32) 2016-08-110000-00-00NoNoCurrent
31722-581-603172205816060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-581-60) 2016-08-110000-00-00NoNoCurrent