FDA.reportPublic FDA data

Duloxetine D/R

Product NDC
72189-608
11-digit product format
721890608
Labeler code
72189
Product ID
72189-608_2ef97557-bb95-c5c8-e063-6294a90a56eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine D/R
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA090694
Marketing category
ANDA
Marketing start
2025-01-16
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 D/R
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULOXETINE HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596934

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
72189-608-30Duloxetine D/R30 in 1 BOTTLECAPSULE, DELAYED RELEASE303
72189-608-60Duloxetine D/R60 in 1 BOTTLECAPSULE, DELAYED RELEASE603
72189-608-90Duloxetine D/R90 in 1 BOTTLECAPSULE, DELAYED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-608-30EA - Each72189-608a031d63b-0745-4a36-b823-c2f9f0802be312025-02-10
72189-608-60EA - Each72189-608e17896c5-2117-463e-93cc-edb9f4bdb7e212025-03-04
72189-608-90EA - Each72189-60871b5db1c-0d9d-4b25-bf02-2afbd238692512025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-608DULOXETINE D/R CAPSULE, DELAYED RELEASE [DIRECT_RX]3Current NDC, 3 package rows20250227_2bd76155-709b-86ad-e063-6294a90aa1c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN2bd76155-709b-86ad-e063-6294a90aa1c53
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD2bd76155-709b-86ad-e063-6294a90aa1c53
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY2bd76155-709b-86ad-e063-6294a90aa1c53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-608-307218906083030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72189-608-30) 2025-01-16NoNoHistorical
72189-608-607218906086060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72189-608-60) 2025-01-16NoNoHistorical
72189-608-907218906089090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72189-608-90) 2025-01-16NoNoHistorical