FDA.reportPublic FDA data

Duloxetine Hydrochloride

Product NDC
50090-3317
11-digit product format
500903317
Labeler code
50090
Product ID
50090-3317_7b81ca32-a8e9-4d08-9339-6ed5de52fa16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine Hydrochloride
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202045
Marketing category
ANDA
Marketing start
2014-06-13
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
50090-3317-02020-01-31C16284748780-19d75b9d1-12f9-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
50090-3317-0Duloxetine Hydrochloride33 in 1 BOX, UNIT-DOSECAPSULE, DELAYED RELEASE336
50090-3317-0Duloxetine Hydrochloride1 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3317-0EA - Each50090-3317df38ac45-54e2-4ab2-9b46-c22baf8c71e612021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3317DULOXETINE HYDROCHLORIDE (DULOXETINE HYDROCHLORIDE ) CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]6Legacy NDC, 2 package rows20180821_605e149d-d007-44da-a66a-f8f081447807.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN605e149d-d007-44da-a66a-f8f0814478076
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD605e149d-d007-44da-a66a-f8f0814478076
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY605e149d-d007-44da-a66a-f8f0814478076

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-3317-05009033170033 in 1 BOX, UNIT-DOSEHistorical