FDA.reportPublic FDA data

Duloxetine

Product NDC
68180-294
11-digit product format
681800294
Labeler code
68180
Product ID
68180-294_7efa28f3-0b15-4e1c-835f-2f1dff37bee8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA090694
Marketing category
ANDA
Marketing start
2013-12-11
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULOXETINE HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596926, 596930, 596934, 616402

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
68180-294-03Duloxetine1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100025
68180-294-06Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE3025
68180-294-07Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE6025
68180-294-09Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE9025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-294-03EA - Each68180-294d1e0f5ff-f0d6-4884-a39c-1681ba80be8512014-04-03
68180-294-06EA - Each68180-294571a4a4c-869c-4dce-a1c0-c71b1849eda812014-01-04
68180-294-07EA - Each68180-2947cfd3b92-fb4b-4c1f-b516-83ec8727916a12014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]13
DULOXETINEACTIVE MOIETYO5TNM5N07UDULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]13
AMMONIAINACTIVE INGREDIENT5138Q19F1XDULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]13
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]13
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]13
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]13
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]13
GELATININACTIVE INGREDIENT2G86QN327LDULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]13
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)INACTIVE INGREDIENTG4U024CQK6DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]13
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]13
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]13
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]13
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TDULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]13
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]13
SHELLACINACTIVE INGREDIENT46N107B71ODULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]13
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]13
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJDULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]13
TALCINACTIVE INGREDIENT7SEV7J4R1UDULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]13
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-294DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]24Current NDC, Legacy NDC, 4 package rows20250124_829a4f51-c882-4b64-81f3-abfb03a52ebe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN829a4f51-c882-4b64-81f3-abfb03a52ebe25
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN829a4f51-c882-4b64-81f3-abfb03a52ebe25
616402DULoxetine 40 MG Delayed Release Oral CapsulePSN829a4f51-c882-4b64-81f3-abfb03a52ebe25
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN829a4f51-c882-4b64-81f3-abfb03a52ebe25
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD829a4f51-c882-4b64-81f3-abfb03a52ebe25
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD829a4f51-c882-4b64-81f3-abfb03a52ebe25
616402duloxetine 40 MG Delayed Release Oral CapsuleSCD829a4f51-c882-4b64-81f3-abfb03a52ebe25
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD829a4f51-c882-4b64-81f3-abfb03a52ebe25
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY829a4f51-c882-4b64-81f3-abfb03a52ebe25
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY829a4f51-c882-4b64-81f3-abfb03a52ebe25
616402duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral CapsuleSY829a4f51-c882-4b64-81f3-abfb03a52ebe25
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY829a4f51-c882-4b64-81f3-abfb03a52ebe25
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN2be9e5fb-011e-424b-b504-df2a28b5271d13
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD2be9e5fb-011e-424b-b504-df2a28b5271d13
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY2be9e5fb-011e-424b-b504-df2a28b5271d13
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN54749431-430e-4532-97f7-4b1cd8dd252e3
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN54749431-430e-4532-97f7-4b1cd8dd252e3
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN54749431-430e-4532-97f7-4b1cd8dd252e3
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD54749431-430e-4532-97f7-4b1cd8dd252e3
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD54749431-430e-4532-97f7-4b1cd8dd252e3
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD54749431-430e-4532-97f7-4b1cd8dd252e3
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY54749431-430e-4532-97f7-4b1cd8dd252e3
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY54749431-430e-4532-97f7-4b1cd8dd252e3
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY54749431-430e-4532-97f7-4b1cd8dd252e3
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN41c54fb7-03f8-2326-e063-6394a90a63521
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN3ac53025-8a99-31de-e063-6294a90a53d21
596926DULoxetine 20 MG Delayed Release Oral CapsulePSNbe0261c7-fb5e-4ba6-b7fb-13a1fecb5f751
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD41c54fb7-03f8-2326-e063-6394a90a63521
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD3ac53025-8a99-31de-e063-6294a90a53d21
596926duloxetine 20 MG Delayed Release Oral CapsuleSCDbe0261c7-fb5e-4ba6-b7fb-13a1fecb5f751
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY41c54fb7-03f8-2326-e063-6394a90a63521
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY3ac53025-8a99-31de-e063-6294a90a53d21
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSYbe0261c7-fb5e-4ba6-b7fb-13a1fecb5f751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-294-03681800294031000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-294-03) 2013-12-110000-00-00NoNoCurrent
68180-294-066818002940630 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-294-06) 2013-12-110000-00-00NoNoCurrent
68180-294-076818002940760 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-294-07) 2013-12-110000-00-00NoNoCurrent
68180-294-096818002940990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-294-09) 2013-12-110000-00-00NoNoCurrent