FDA.reportPublic FDA data

Duloxetine

Product NDC
0228-2891
11-digit product format
002282891
Labeler code
0228
Product ID
0228-2891_8b9c71de-82c9-44a5-b2d5-8c6b3141e4ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA090776
Marketing category
ANDA
Marketing start
2013-12-17
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
2027-12-31
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

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
0228-2891-03Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS3028
0228-2891-50Duloxetine500 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS50028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-2891-03EA - Each0228-2891f6da7b09-5772-46a2-bfa4-b8eaa2f4628a12014-01-04
0228-2891-50EA - Each0228-289183c1fce5-d750-49c4-ab22-2de15d2ed9fb12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]13
DULOXETINEACTIVE MOIETYO5TNM5N07UDULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]13
AMMONIAINACTIVE INGREDIENT5138Q19F1XDULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]13
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]13
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]13
GELATININACTIVE INGREDIENT2G86QN327LDULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]13
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PDULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]13
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KDULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]13
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]13
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TDULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]13
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]13
SHELLACINACTIVE INGREDIENT46N107B71ODULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]13
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]13
SUCROSEINACTIVE INGREDIENTC151H8M554DULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]13
TALCINACTIVE INGREDIENT7SEV7J4R1UDULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]13
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-2891DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]26Current NDC, Legacy NDC, 2 package rows20240510_9dab9154-b86f-40dc-a4d1-18e6534dbc78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN9dab9154-b86f-40dc-a4d1-18e6534dbc7828
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN9dab9154-b86f-40dc-a4d1-18e6534dbc7828
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN9dab9154-b86f-40dc-a4d1-18e6534dbc7828
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD9dab9154-b86f-40dc-a4d1-18e6534dbc7828
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD9dab9154-b86f-40dc-a4d1-18e6534dbc7828
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD9dab9154-b86f-40dc-a4d1-18e6534dbc7828
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY9dab9154-b86f-40dc-a4d1-18e6534dbc7828
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY9dab9154-b86f-40dc-a4d1-18e6534dbc7828
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY9dab9154-b86f-40dc-a4d1-18e6534dbc7828
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNb33cbab8-1962-cb66-e053-2a95a90a4ae78
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDb33cbab8-1962-cb66-e053-2a95a90a4ae78
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYb33cbab8-1962-cb66-e053-2a95a90a4ae78
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN7c755ca3-0855-4b54-80a8-01b85f8e644a1
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNc5aac428-d929-4688-a9d5-4e9314aa62cc1
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN2d7c2a64-2ce0-f222-e063-6294a90a90561
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNc5aac428-d929-4688-a9d5-4e9314aa62cc1
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDc5aac428-d929-4688-a9d5-4e9314aa62cc1
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD2d7c2a64-2ce0-f222-e063-6294a90a90561
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD7c755ca3-0855-4b54-80a8-01b85f8e644a1
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDc5aac428-d929-4688-a9d5-4e9314aa62cc1
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY7c755ca3-0855-4b54-80a8-01b85f8e644a1
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY2d7c2a64-2ce0-f222-e063-6294a90a90561
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYc5aac428-d929-4688-a9d5-4e9314aa62cc1
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYc5aac428-d929-4688-a9d5-4e9314aa62cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0228-2891-030022828910330 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0228-2891-03) 2013-12-170000-00-00NoNoCurrent
0228-2891-5000228289150500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0228-2891-50) 2014-09-050000-00-00NoNoCurrent