Duloxetine

Product NDC
68382-385
11-digit product format
683820385
Labeler code
68382
Product ID
68382-385_f95fe0a8-5492-4210-87a3-1881b4e98372
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA090739
Marketing category
ANDA
Marketing start
2014-05-27
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-385-14EA - Each68382-3854ac6aae6-47d7-42ba-8547-b0b87c2b408412014-12-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN7020f4cd-4e10-4334-8eb0-ea35d984aba91
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD7020f4cd-4e10-4334-8eb0-ea35d984aba91
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY7020f4cd-4e10-4334-8eb0-ea35d984aba91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-385-066838203850630 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-385-06) 2014-05-270000-00-00NoNoCurrent
68382-385-146838203851460 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-385-14) 2014-05-270000-00-00NoNoCurrent
68382-385-166838203851690 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-385-16) 2014-05-270000-00-00NoNoCurrent