FDA.reportPublic FDA data

Duloxetine

Product NDC
71205-525
11-digit product format
712050525
Labeler code
71205
Product ID
71205-525_4318dfda-092c-4ade-83c5-581bc968f391
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090776
Marketing category
ANDA
Marketing start
2013-12-17
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
71205-525-30Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS303
71205-525-60Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS603
71205-525-90Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-525-30EA - Each71205-525b1e63792-cdcc-441d-a041-3df79a78b09812021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-525DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20241024_3dec1805-9a95-462e-8784-303004d500b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN3dec1805-9a95-462e-8784-303004d500b13
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD3dec1805-9a95-462e-8784-303004d500b13
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY3dec1805-9a95-462e-8784-303004d500b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-525-307120505253030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71205-525-30) 2021-01-220000-00-00NoNoCurrent
71205-525-607120505256060 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71205-525-60) 2021-01-220000-00-00NoNoCurrent
71205-525-907120505259090 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71205-525-90) 2021-01-220000-00-00NoNoCurrent