FDA.reportPublic FDA data

Duloxetine Hydrochloride

Product NDC
50436-0018
11-digit product format
504360018
Labeler code
50436
Product ID
50436-0018_6ffccdca-0b3b-47bf-b89e-9af6f2b43181
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine Hydrochloride
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA090778
Marketing category
ANDA
Marketing start
2013-12-11
Marketing end
0000-00-00
Substance
DULOXETINE HYDROCHLORIDE
Active strength
30 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
2019-12-31
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
50436-0018-12020-01-31C16284748780-19d75b9d1-0f2a-f424-e053-dadaa90a57ceThese 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
50436-0018-22020-01-31C16284748780-19d75b9d1-0f2a-f424-e053-dadaa90a57ceThese 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
50436-0018-1Duloxetine Hydrochloride30 in 1 BOTTLECAPSULE, DELAYED RELEASE308
50436-0018-2Duloxetine Hydrochloride60 in 1 BOTTLECAPSULE, DELAYED RELEASE608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0018-1EA - Each50436-00183e54dee5-7d4f-4524-89c9-8f734677eaa512017-11-06
50436-0018-2EA - Each50436-00183746fed3-3872-4ec4-a6c5-432b9f80e6ce12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0018DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]8Legacy NDC, 2 package rows20170815_fc9ad025-88c8-4c3d-8cd0-3ad60a7a47e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNfc9ad025-88c8-4c3d-8cd0-3ad60a7a47e88
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNfc9ad025-88c8-4c3d-8cd0-3ad60a7a47e88
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDfc9ad025-88c8-4c3d-8cd0-3ad60a7a47e88
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDfc9ad025-88c8-4c3d-8cd0-3ad60a7a47e88
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYfc9ad025-88c8-4c3d-8cd0-3ad60a7a47e88
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYfc9ad025-88c8-4c3d-8cd0-3ad60a7a47e88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0018-15043600180130 in 1 BOTTLEHistorical
50436-0018-25043600180260 in 1 BOTTLEHistorical