FDA.reportPublic FDA data

Duloxetine

Product NDC
71205-005
11-digit product format
712050005
Labeler code
71205
Product ID
71205-005_9897ad4f-87a5-40c8-8c79-7638eae42437
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA208706
Marketing category
ANDA
Marketing start
2017-03-16
Substance
DULOXETINE HYDROCHLORIDE
Active strength
20 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULOXETINE HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596926

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-005-30Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE305
71205-005-60Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE605
71205-005-90Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-005-30EA - Each71205-0058d661907-9979-4397-af53-9c7c5aa848fa12026-02-05
71205-005-60EA - Each71205-005a7f7a0fd-f55c-480f-8761-ab135799c10c12018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-005DULOXETINE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20221104_5410084d-a7db-4da1-a45d-24b91ef50404.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN5410084d-a7db-4da1-a45d-24b91ef504045
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD5410084d-a7db-4da1-a45d-24b91ef504045
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY5410084d-a7db-4da1-a45d-24b91ef504045

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-005-307120500053030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-005-30) 2018-04-020000-00-00NoNoCurrent
71205-005-607120500056060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-005-60) 2018-04-020000-00-00NoNoCurrent
71205-005-907120500059090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-005-90) 2018-04-020000-00-00NoNoCurrent