FDA.reportPublic FDA data

Duloxetine

Product NDC
50436-0199
11-digit product format
504360199
Labeler code
50436
Product ID
50436-0199_413b4906-0a0e-4794-a376-a8bf91bde096
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA208706
Marketing category
ANDA
Marketing start
2017-03-16
Marketing end
0000-00-00
Substance
DULOXETINE HYDROCHLORIDE
Active strength
60 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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-0199-12023-01-30C16284748780-1f386c649-de4c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DULOXETINE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DULOXETINE DELAYED-RELEASE CAPSULES. DULOXETINE delayed-release capsules, for oral use. Initial U.S. Approval: 2004
50436-0199-22023-01-30C16284748780-1f386c649-de4c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DULOXETINE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DULOXETINE DELAYED-RELEASE CAPSULES. DULOXETINE delayed-release capsules, for oral use. Initial U.S. Approval: 2004
50436-0199-32023-01-30C16284748780-1f386c649-de4c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DULOXETINE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DULOXETINE DELAYED-RELEASE CAPSULES. DULOXETINE delayed-release capsules, for oral use. Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0199-1Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE303
50436-0199-2Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE603
50436-0199-3Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0199-1EA - Each50436-0199444e8373-e4fb-4511-a3a6-0e352c3c9d8c12021-10-08
50436-0199-2EA - Each50436-0199075ef755-27e4-4d55-83a4-a833d3bdc80312021-10-08
50436-0199-3EA - Each50436-019930101c39-c7ca-4fcf-8ac4-80ae6831267412021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0199DULOXETINE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]3Legacy NDC, 3 package rows20210825_2425f770-a264-4aec-9439-7c2dbd2da548.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN2425f770-a264-4aec-9439-7c2dbd2da5483
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN2425f770-a264-4aec-9439-7c2dbd2da5483
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD2425f770-a264-4aec-9439-7c2dbd2da5483
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD2425f770-a264-4aec-9439-7c2dbd2da5483
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY2425f770-a264-4aec-9439-7c2dbd2da5483
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY2425f770-a264-4aec-9439-7c2dbd2da5483

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50436-0199-15043601990130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50436-0199-1) 2021-08-240000-00-00NoNoCurrent
50436-0199-25043601990260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50436-0199-2) 2021-08-240000-00-00NoNoCurrent
50436-0199-35043601990390 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50436-0199-3) 2021-08-240000-00-00NoNoCurrent