FDA.reportPublic FDA data

Duloxetine

Product NDC
51407-819
11-digit product format
514070819
Labeler code
51407
Product ID
51407-819_30de843c-548f-4ced-e063-6394a90aac20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA203088
Marketing category
ANDA
Marketing start
2014-06-11
Substance
DULOXETINE HYDROCHLORIDE
Active strength
60 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
Brand name suffix
Delayed-Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULOXETINE HYDROCHLORIDE60 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
51407-819-10DuloxetineDelayed-Release1000 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS10003
51407-819-30DuloxetineDelayed-Release30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-819-10EA - Each51407-819706b8e92-2db9-47e1-bfe5-ea8004db0d4112023-08-08
51407-819-30EA - Each51407-819135b2fab-bcfe-458f-a1af-d27b628a877312023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-819DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]3Current NDC, 2 package rows20250411_00628e5e-4c5b-2573-e063-6294a90a0e3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN00628e5e-4c5b-2573-e063-6294a90a0e3b3
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN00628e5e-4c5b-2573-e063-6294a90a0e3b3
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN00628e5e-4c5b-2573-e063-6294a90a0e3b3
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN3bae1317-4cc8-4d86-b1b6-15edee733a6d3
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD00628e5e-4c5b-2573-e063-6294a90a0e3b3
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD00628e5e-4c5b-2573-e063-6294a90a0e3b3
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD00628e5e-4c5b-2573-e063-6294a90a0e3b3
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD3bae1317-4cc8-4d86-b1b6-15edee733a6d3
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY00628e5e-4c5b-2573-e063-6294a90a0e3b3
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY00628e5e-4c5b-2573-e063-6294a90a0e3b3
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY00628e5e-4c5b-2573-e063-6294a90a0e3b3
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY3bae1317-4cc8-4d86-b1b6-15edee733a6d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51407-819-10514070819101000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51407-819-10) 2023-07-12NoNoHistorical
51407-819-305140708193030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51407-819-30) 2023-07-12NoNoHistorical