FDA.reportPublic FDA data

Duloxetine

Product NDC
51991-746
11-digit product format
519910746
Labeler code
51991
Product ID
51991-746_32327581-bdab-41ac-9adc-bf208e1c4e42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA203088
Marketing category
ANDA
Marketing start
2014-06-11
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
Brand name suffix
Delayed-Release
Listing expiration
2026-12-31

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
51991-746-05Duloxetine Delayed-Release500 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS50026
51991-746-06Duloxetine Delayed-Release60 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS6026
51991-746-90Duloxetine Delayed-Release90 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS9026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-746-05EA - Each51991-7465ab1071a-03f6-4051-9488-aaba31e1cfbc12014-07-02
51991-746-90EA - Each51991-746af9e7f1f-194f-4b67-a757-ebc4bc04ae7f12014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]8
DULOXETINEACTIVE MOIETYO5TNM5N07UDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]8
AMMONIAINACTIVE INGREDIENT5138Q19F1XDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]8
GELATININACTIVE INGREDIENT2G86QN327LDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]8
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]8
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]8
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]8
SHELLACINACTIVE INGREDIENT46N107B71ODULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]8
SUCROSEINACTIVE INGREDIENTC151H8M554DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1UDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]8
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]8
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
DULOXETINEACTIVE MOIETYO5TNM5N07UDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71ODULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-746DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]26Current NDC, Legacy NDC, 3 package rows20250209_caef6f50-1571-4ec7-8f8c-42b924d323ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSNb25c01e0-273a-4f8f-a37e-9b17e5cf378f105
596926duloxetine 20 MG Delayed Release Oral CapsuleSCDb25c01e0-273a-4f8f-a37e-9b17e5cf378f105
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSYb25c01e0-273a-4f8f-a37e-9b17e5cf378f105
596926DULoxetine 20 MG Delayed Release Oral CapsulePSNa5804a0b-ceae-4ebd-bba0-bfc10e21b90d102
596926duloxetine 20 MG Delayed Release Oral CapsuleSCDa5804a0b-ceae-4ebd-bba0-bfc10e21b90d102
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSYa5804a0b-ceae-4ebd-bba0-bfc10e21b90d102
596926DULoxetine 20 MG Delayed Release Oral CapsulePSNcaef6f50-1571-4ec7-8f8c-42b924d323ee26
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNcaef6f50-1571-4ec7-8f8c-42b924d323ee26
616402DULoxetine 40 MG Delayed Release Oral CapsulePSNcaef6f50-1571-4ec7-8f8c-42b924d323ee26
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNcaef6f50-1571-4ec7-8f8c-42b924d323ee26
596926duloxetine 20 MG Delayed Release Oral CapsuleSCDcaef6f50-1571-4ec7-8f8c-42b924d323ee26
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDcaef6f50-1571-4ec7-8f8c-42b924d323ee26
616402duloxetine 40 MG Delayed Release Oral CapsuleSCDcaef6f50-1571-4ec7-8f8c-42b924d323ee26
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDcaef6f50-1571-4ec7-8f8c-42b924d323ee26
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSYcaef6f50-1571-4ec7-8f8c-42b924d323ee26
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYcaef6f50-1571-4ec7-8f8c-42b924d323ee26
616402duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral CapsuleSYcaef6f50-1571-4ec7-8f8c-42b924d323ee26
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYcaef6f50-1571-4ec7-8f8c-42b924d323ee26
596926DULoxetine 20 MG Delayed Release Oral CapsulePSNa891f20f-83ff-4960-81ef-9e74d01a452e20
596926DULoxetine 20 MG Delayed Release Oral CapsulePSNf535fcd2-a50a-4423-85d9-705fd2d9a47020
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNf535fcd2-a50a-4423-85d9-705fd2d9a47020
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNf535fcd2-a50a-4423-85d9-705fd2d9a47020
596926duloxetine 20 MG Delayed Release Oral CapsuleSCDf535fcd2-a50a-4423-85d9-705fd2d9a47020
596926duloxetine 20 MG Delayed Release Oral CapsuleSCDa891f20f-83ff-4960-81ef-9e74d01a452e20
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDf535fcd2-a50a-4423-85d9-705fd2d9a47020
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDf535fcd2-a50a-4423-85d9-705fd2d9a47020
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSYa891f20f-83ff-4960-81ef-9e74d01a452e20
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSYf535fcd2-a50a-4423-85d9-705fd2d9a47020
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYf535fcd2-a50a-4423-85d9-705fd2d9a47020
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYf535fcd2-a50a-4423-85d9-705fd2d9a47020
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN29eacc40-cbec-4cc9-8556-773346617e856
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD29eacc40-cbec-4cc9-8556-773346617e856
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY29eacc40-cbec-4cc9-8556-773346617e856
596926DULoxetine 20 MG Delayed Release Oral CapsulePSNbe33f3cb-6fd1-4377-816e-84bd49370e9e5
596926duloxetine 20 MG Delayed Release Oral CapsuleSCDbe33f3cb-6fd1-4377-816e-84bd49370e9e5
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSYbe33f3cb-6fd1-4377-816e-84bd49370e9e5
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN9078217c-16f4-a543-e053-2a95a90a31f24
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN7000c48f-77f3-4447-b223-fde99886ed304
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD9078217c-16f4-a543-e053-2a95a90a31f24
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD7000c48f-77f3-4447-b223-fde99886ed304
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY9078217c-16f4-a543-e053-2a95a90a31f24
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY7000c48f-77f3-4447-b223-fde99886ed304
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN407b62b9-5b32-4bac-a2b0-7df4992792483
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD407b62b9-5b32-4bac-a2b0-7df4992792483
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY407b62b9-5b32-4bac-a2b0-7df4992792483
596926DULoxetine 20 MG Delayed Release Oral CapsulePSNdf61b895-c358-827b-e053-2995a90a9b602
596926duloxetine 20 MG Delayed Release Oral CapsuleSCDdf61b895-c358-827b-e053-2995a90a9b602
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSYdf61b895-c358-827b-e053-2995a90a9b602
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN7dc9638a-dbba-c190-e053-2a91aa0a1be91
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN441a46f0-ecc7-4448-e054-00144ff88e881
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD7dc9638a-dbba-c190-e053-2a91aa0a1be91
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD441a46f0-ecc7-4448-e054-00144ff88e881
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY441a46f0-ecc7-4448-e054-00144ff88e881
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY7dc9638a-dbba-c190-e053-2a91aa0a1be91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51991-746-0551991074605500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-746-05) 2014-06-110000-00-00NoNoCurrent
51991-746-065199107460660 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-746-06) 2014-06-110000-00-00NoNoCurrent
51991-746-905199107469090 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-746-90) 2014-06-110000-00-00NoNoCurrent