FDA.reportPublic FDA data

Duloxetine

Product NDC
70518-1765
11-digit product format
705181765
Labeler code
70518
Product ID
70518-1765_49741c96-db6d-402a-e063-6394a90a07e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090694
Marketing category
ANDA
Marketing start
2019-01-02
Substance
DULOXETINE HYDROCHLORIDE
Active strength
30 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Duloxetine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULOXETINE HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596930

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
70518-1765-0Duloxetine30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE3013
70518-1765-1Duloxetine90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE9013
70518-1765-2Duloxetine90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE9013
70518-1765-3Duloxetine30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE3013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1765DULOXETINE CAPSULE, DELAYED RELEASE [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 4 package rows20250228_1d3a45f3-3854-4d0c-9241-770aa24063fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN1d3a45f3-3854-4d0c-9241-770aa24063fd13
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD1d3a45f3-3854-4d0c-9241-770aa24063fd13
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY1d3a45f3-3854-4d0c-9241-770aa24063fd13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-1765-07051817650030 in 1 BLISTER PACKHistorical
70518-1765-17051817650190 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1765-1) 2025-01-22NoNoHistorical
70518-1765-27051817650290 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1765-2) 2025-06-23NoNoHistorical
70518-1765-37051817650330 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-1765-3) 2025-08-08NoNoHistorical