FDA.reportPublic FDA data

Duloxetine Hydrochloride

Product NDC
33342-160
11-digit product format
333420160
Labeler code
33342
Product ID
33342-160_d2bdee38-c510-432f-bf05-a8a573cf459c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine Hydrochloride
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA204815
Marketing category
ANDA
Marketing start
2017-03-24
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Duloxetine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULOXETINE HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596926, 596930, 596934

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-160-09Duloxetine Hydrochloride60 in 1 BOTTLECAPSULE, DELAYED RELEASE6010
33342-160-10Duloxetine Hydrochloride90 in 1 BOTTLECAPSULE, DELAYED RELEASE9010
33342-160-12Duloxetine Hydrochloride10 in 1 CARTONCAPSULE, DELAYED RELEASE1010
33342-160-12Duloxetine Hydrochloride10 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE1010
33342-160-44Duloxetine Hydrochloride1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-160-09EA - Each33342-160aa212acd-a48b-4575-a60c-1da2c5a5459212018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-160DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [MACLEODS PHARMACEUTICALS LIMITED]9Current NDC, Legacy NDC, 5 package rows20230926_177ce798-3924-416b-ba37-23dfa911a43b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN177ce798-3924-416b-ba37-23dfa911a43b10
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN177ce798-3924-416b-ba37-23dfa911a43b10
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN177ce798-3924-416b-ba37-23dfa911a43b10
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD177ce798-3924-416b-ba37-23dfa911a43b10
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD177ce798-3924-416b-ba37-23dfa911a43b10
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD177ce798-3924-416b-ba37-23dfa911a43b10
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY177ce798-3924-416b-ba37-23dfa911a43b10
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY177ce798-3924-416b-ba37-23dfa911a43b10
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY177ce798-3924-416b-ba37-23dfa911a43b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-160-093334201600960 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-160-09) 2017-03-240000-00-00NoNoCurrent
33342-160-103334201601090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-160-10) 2017-03-240000-00-00NoNoCurrent
33342-160-123334201601210 BLISTER PACK in 1 CARTON (33342-160-12) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK10 blister pack2017-03-240000-00-00NoNoCurrent
33342-160-44333420160441000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-160-44) 2017-03-240000-00-00NoNoCurrent