FDA.reportPublic FDA data

Cymbalta

Product NDC
0002-3270
11-digit product format
000023270
Labeler code
0002
Product ID
0002-3270_aa5061b1-f237-425a-9d05-575c333dfd37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine hydrochloride
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Eli Lilly and Company
Application
NDA021427
Marketing category
NDA
Marketing start
2010-01-15
Marketing end
2026-10-02
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cymbalta

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULOXETINE HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596926, 596928, 596930, 596932, 596934, 615186

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-3270-30Cymbalta30 in 1 BOTTLECAPSULE, DELAYED RELEASE3090

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-3270-01EA - Each0002-32707149c6ef-ec54-4fd3-9083-2e15125bea6212012-07-24
0002-3270-04EA - Each0002-3270ad73f24c-7d72-4830-97ae-1a9ba1b8ec5812012-07-24
0002-3270-30EA - Each0002-3270581237c9-1b60-4246-8dff-bfaab7eb889812012-07-24
0002-3270-33EA - Each0002-32709366b8c5-1181-45d4-8587-e383e34e2a4512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Duloxetine hydrochlorideACTIVE INGREDIENT9044SC542WCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [ELI LILLY AND COMPANY]66
DuloxetineACTIVE MOIETYO5TNM5N07UCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [ELI LILLY AND COMPANY]66
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [ELI LILLY AND COMPANY]66
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [ELI LILLY AND COMPANY]66
GelatinINACTIVE INGREDIENT2G86QN327LCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [ELI LILLY AND COMPANY]66
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)INACTIVE INGREDIENT24P2YXD2PWCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [ELI LILLY AND COMPANY]66
HypromellosesINACTIVE INGREDIENT3NXW29V3WOCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [ELI LILLY AND COMPANY]66
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [ELI LILLY AND COMPANY]66
SucroseINACTIVE INGREDIENTC151H8M554CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [ELI LILLY AND COMPANY]66
TalcINACTIVE INGREDIENT7SEV7J4R1UCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [ELI LILLY AND COMPANY]66
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [ELI LILLY AND COMPANY]66
Triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [ELI LILLY AND COMPANY]66
Duloxetine hydrochlorideACTIVE INGREDIENT9044SC542WCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]1
DuloxetineACTIVE MOIETYO5TNM5N07UCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]1
GelatinINACTIVE INGREDIENT2G86QN327LCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]1
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)INACTIVE INGREDIENT24P2YXD2PWCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]1
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]1
SucroseINACTIVE INGREDIENTC151H8M554CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]1
TalcINACTIVE INGREDIENT7SEV7J4R1UCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]1
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]1
Triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMCYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-3270CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [ELI LILLY AND COMPANY]89Current NDC, Legacy NDC, 1 package rows20241206_2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596928Cymbalta 20 MG Delayed Release Oral CapsulePSN2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba90
596932Cymbalta 30 MG Delayed Release Oral CapsulePSN2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba90
615186Cymbalta 60 MG Delayed Release Oral CapsulePSN2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba90
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba90
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba90
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba90
596928duloxetine 20 MG Delayed Release Oral Capsule [Cymbalta]SBD2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba90
596932duloxetine 30 MG Delayed Release Oral Capsule [Cymbalta]SBD2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba90
615186duloxetine 60 MG Delayed Release Oral Capsule [Cymbalta]SBD2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba90
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba90
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba90
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba90
596928Cymbalta 20 MG (as duloxetine hydrochloride 22.4 MG) Delayed Release Oral CapsuleSY2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba90
596928Cymbalta 20 MG Delayed Release Oral CapsuleSY2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba90
596932Cymbalta 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba90
596932Cymbalta 30 MG Delayed Release Oral CapsuleSY2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba90
615186Cymbalta 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba90
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba90
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba90
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba90
615186Cymbalta 60 MG Delayed Release Oral CapsulePSN059d730b-4294-47e1-8399-4cb8c468cee81
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN059d730b-4294-47e1-8399-4cb8c468cee81
615186duloxetine 60 MG Delayed Release Oral Capsule [Cymbalta]SBD059d730b-4294-47e1-8399-4cb8c468cee81
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD059d730b-4294-47e1-8399-4cb8c468cee81
615186Cymbalta 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY059d730b-4294-47e1-8399-4cb8c468cee81
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY059d730b-4294-47e1-8399-4cb8c468cee81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0002-3270-04000023270041000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0002-3270-04) 2010-01-152021-05-31NoNoCurrent
0002-3270-300000232703030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0002-3270-30) 2010-01-150000-00-00NoNoCurrent