FDA.reportPublic FDA data

Duloxetine

Product NDC
25000-610
11-digit product format
250000610
Labeler code
25000
Product ID
25000-610_c8aa863f-eb1f-4b66-9ec6-2af2c7958248
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine Hydrochloride
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
MARKSANS PHARMA LIMITED
Application
ANDA090723
Marketing category
ANDA
Marketing start
2022-05-27
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
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
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25000-610-03Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE303
25000-610-07Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25000-610DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [MARKSANS PHARMA LIMITED]3Current NDC, Legacy NDC, 2 package rows20231011_3686cde5-f76d-4d16-aa5d-caceb8408f8c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN3686cde5-f76d-4d16-aa5d-caceb8408f8c3
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN3686cde5-f76d-4d16-aa5d-caceb8408f8c3
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN3686cde5-f76d-4d16-aa5d-caceb8408f8c3
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD3686cde5-f76d-4d16-aa5d-caceb8408f8c3
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD3686cde5-f76d-4d16-aa5d-caceb8408f8c3
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD3686cde5-f76d-4d16-aa5d-caceb8408f8c3
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY3686cde5-f76d-4d16-aa5d-caceb8408f8c3
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY3686cde5-f76d-4d16-aa5d-caceb8408f8c3
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY3686cde5-f76d-4d16-aa5d-caceb8408f8c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
25000-610-032500006100330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (25000-610-03) 2022-05-270000-00-00NoNoCurrent
25000-610-072500006100790 CAPSULE, DELAYED RELEASE in 1 BOTTLE (25000-610-07) 2022-05-270000-00-00NoNoCurrent