FDA.reportPublic FDA data

Duloxetine

Product NDC
50436-0748
11-digit product format
504360748
Labeler code
50436
Product ID
50436-0748_7dfff379-0654-4eb1-a1a6-756e325fa8c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA203088
Marketing category
ANDA
Marketing start
2014-06-11
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
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-0748-12023-01-30C16284748780-1f386c649-c611-0266-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.
50436-0748-22023-01-30C16284748780-1f386c649-c611-0266-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.
50436-0748-32023-01-30C16284748780-1f386c649-c611-0266-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
50436-0748-1Duloxetine Delayed-Release30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS303
50436-0748-2Duloxetine Delayed-Release60 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS603
50436-0748-3Duloxetine Delayed-Release90 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0748DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [UNIT DOSE SERVICES]3Legacy NDC, 3 package rows20210818_dbd00f99-d190-48cd-85f4-b217b767aa1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNdbd00f99-d190-48cd-85f4-b217b767aa1a3
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNdbd00f99-d190-48cd-85f4-b217b767aa1a3
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDdbd00f99-d190-48cd-85f4-b217b767aa1a3
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDdbd00f99-d190-48cd-85f4-b217b767aa1a3
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYdbd00f99-d190-48cd-85f4-b217b767aa1a3
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYdbd00f99-d190-48cd-85f4-b217b767aa1a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50436-0748-15043607480130 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (50436-0748-1) 2021-08-170000-00-00NoNoCurrent
50436-0748-25043607480260 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (50436-0748-2) 2021-08-170000-00-00NoNoCurrent
50436-0748-35043607480390 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (50436-0748-3) 2021-08-170000-00-00NoNoCurrent