FDA.reportPublic FDA data

Duloxetine

Product NDC
68180-295
11-digit product format
681800295
Labeler code
68180
Product ID
68180-295_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
30 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 HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-295-03Duloxetine1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100025
68180-295-06Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE3025
68180-295-09Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE9025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-295-03EA - Each68180-295ab8b1a12-e6cc-4469-9a84-aafe96c5f5eb12014-04-03
68180-295-06EA - Each68180-295bbc58234-fb3f-4876-87e6-5e62c6c31e7012014-01-04
68180-295-09EA - Each68180-295e67c55d4-0f46-48a6-b52e-d65167134f3312014-01-04

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
68180-295DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]24Current NDC, Legacy NDC, 3 package rows20250124_829a4f51-c882-4b64-81f3-abfb03a52ebe.zip
68180-295DULOXICAINE (DULOXETINE AND LIDOCAINE) KIT [V2 PHARMA, LLC]8Current NDC, Legacy NDC20230127_fa68f759-877b-46bd-94d1-3960da89db2a.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
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNe0381ead-d8bc-43fa-9f12-e0fefcaf7f3d14
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDe0381ead-d8bc-43fa-9f12-e0fefcaf7f3d14
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYe0381ead-d8bc-43fa-9f12-e0fefcaf7f3d14
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN1d3a45f3-3854-4d0c-9241-770aa24063fd13
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD1d3a45f3-3854-4d0c-9241-770aa24063fd13
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY1d3a45f3-3854-4d0c-9241-770aa24063fd13
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNe2352870-3582-4d92-8712-87ad8bdccb8712
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDe2352870-3582-4d92-8712-87ad8bdccb8712
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYe2352870-3582-4d92-8712-87ad8bdccb8712
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNfa68f759-877b-46bd-94d1-3960da89db2a8
1010895lidocaine HCl 4 % Topical CreamPSNfa68f759-877b-46bd-94d1-3960da89db2a8
2597529Lidocream Plus 4 % Topical CreamPSNfa68f759-877b-46bd-94d1-3960da89db2a8
2597529lidocaine hydrochloride 40 MG/ML Topical Cream [Lidocream]SBDfa68f759-877b-46bd-94d1-3960da89db2a8
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDfa68f759-877b-46bd-94d1-3960da89db2a8
1010895lidocaine hydrochloride 40 MG/ML Topical CreamSCDfa68f759-877b-46bd-94d1-3960da89db2a8
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYfa68f759-877b-46bd-94d1-3960da89db2a8
1010895lidocaine hydrochloride 4 % Topical CreamSYfa68f759-877b-46bd-94d1-3960da89db2a8
2597529Lidocream Plus 4 % Topical CreamSYfa68f759-877b-46bd-94d1-3960da89db2a8
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN54749431-430e-4532-97f7-4b1cd8dd252e3
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN9141b9d3-8d4d-43ec-acf9-e1b620590c4b3
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN2e58add7-b85e-2772-e063-6294a90a580d3
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 CapsuleSCD9141b9d3-8d4d-43ec-acf9-e1b620590c4b3
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD54749431-430e-4532-97f7-4b1cd8dd252e3
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD2e58add7-b85e-2772-e063-6294a90a580d3
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
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY9141b9d3-8d4d-43ec-acf9-e1b620590c4b3
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY2e58add7-b85e-2772-e063-6294a90a580d3
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY54749431-430e-4532-97f7-4b1cd8dd252e3
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN19afed24-39ad-daf1-e063-6394a90ad7372
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN19afed24-39ad-daf1-e063-6394a90ad7372
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD19afed24-39ad-daf1-e063-6394a90ad7372
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD19afed24-39ad-daf1-e063-6394a90ad7372
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY19afed24-39ad-daf1-e063-6394a90ad7372
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY19afed24-39ad-daf1-e063-6394a90ad7372
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN39e293d5-c575-49db-8389-7ac2269c49bb1
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD39e293d5-c575-49db-8389-7ac2269c49bb1
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY39e293d5-c575-49db-8389-7ac2269c49bb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-295-03681800295031000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-295-03) 2014-03-060000-00-00NoNoCurrent
68180-295-066818002950630 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-295-06) 2013-12-110000-00-00NoNoCurrent
68180-295-096818002950990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-295-09) 2013-12-110000-00-00NoNoCurrent