FDA.reportPublic FDA data

Duloxetine

Product NDC
27241-097
11-digit product format
272410097
Labeler code
27241
Product ID
27241-097_ae1a8c02-c1fc-474a-9411-cebecd99e339
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA208706
Marketing category
ANDA
Marketing start
2017-03-16
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
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27241-097-05Duloxetine500 in 1 BOTTLECAPSULE, DELAYED RELEASE50018
27241-097-06Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE6018
27241-097-10Duloxetine1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100018
27241-097-90Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-097-06EA - Each27241-097c2fd0673-0283-43e5-9dca-6bb49e02c62912017-09-11
27241-097-10EA - Each27241-09751a5a3f8-7ff5-407f-9b8d-fab8605b348e12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-097DULOXETINE CAPSULE, DELAYED RELEASE [AJANTA PHARMA USA INC.]16Current NDC, Legacy NDC, 4 package rows20230908_2dde979d-b6f8-41d1-96fb-325c75ea3a74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN9286ec0b-45ae-4a09-a0ad-556ec92aab6321
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD9286ec0b-45ae-4a09-a0ad-556ec92aab6321
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY9286ec0b-45ae-4a09-a0ad-556ec92aab6321
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN2dde979d-b6f8-41d1-96fb-325c75ea3a7418
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN2dde979d-b6f8-41d1-96fb-325c75ea3a7418
616402DULoxetine 40 MG Delayed Release Oral CapsulePSN2dde979d-b6f8-41d1-96fb-325c75ea3a7418
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN2dde979d-b6f8-41d1-96fb-325c75ea3a7418
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD2dde979d-b6f8-41d1-96fb-325c75ea3a7418
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD2dde979d-b6f8-41d1-96fb-325c75ea3a7418
616402duloxetine 40 MG Delayed Release Oral CapsuleSCD2dde979d-b6f8-41d1-96fb-325c75ea3a7418
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD2dde979d-b6f8-41d1-96fb-325c75ea3a7418
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY2dde979d-b6f8-41d1-96fb-325c75ea3a7418
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY2dde979d-b6f8-41d1-96fb-325c75ea3a7418
616402duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral CapsuleSY2dde979d-b6f8-41d1-96fb-325c75ea3a7418
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY2dde979d-b6f8-41d1-96fb-325c75ea3a7418
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN5410084d-a7db-4da1-a45d-24b91ef504045
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD5410084d-a7db-4da1-a45d-24b91ef504045
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY5410084d-a7db-4da1-a45d-24b91ef504045
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN7685a825-3c06-433d-ba98-4019c6ed25834
596926DULoxetine 20 MG Delayed Release Oral CapsulePSNf61bd9f3-cd3d-4c76-a110-0f1dcba610af4
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNf61bd9f3-cd3d-4c76-a110-0f1dcba610af4
616402DULoxetine 40 MG Delayed Release Oral CapsulePSNf61bd9f3-cd3d-4c76-a110-0f1dcba610af4
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNf61bd9f3-cd3d-4c76-a110-0f1dcba610af4
596926duloxetine 20 MG Delayed Release Oral CapsuleSCDf61bd9f3-cd3d-4c76-a110-0f1dcba610af4
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD7685a825-3c06-433d-ba98-4019c6ed25834
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDf61bd9f3-cd3d-4c76-a110-0f1dcba610af4
616402duloxetine 40 MG Delayed Release Oral CapsuleSCDf61bd9f3-cd3d-4c76-a110-0f1dcba610af4
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDf61bd9f3-cd3d-4c76-a110-0f1dcba610af4
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY7685a825-3c06-433d-ba98-4019c6ed25834
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSYf61bd9f3-cd3d-4c76-a110-0f1dcba610af4
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYf61bd9f3-cd3d-4c76-a110-0f1dcba610af4
616402duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral CapsuleSYf61bd9f3-cd3d-4c76-a110-0f1dcba610af4
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYf61bd9f3-cd3d-4c76-a110-0f1dcba610af4
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN59d93257-237a-43ac-b1ab-0905246fb60e2
596926DULoxetine 20 MG Delayed Release Oral CapsulePSNf8c0bc80-b34e-daa8-e053-6394a90a05c22
596926duloxetine 20 MG Delayed Release Oral CapsuleSCDf8c0bc80-b34e-daa8-e053-6394a90a05c22
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD59d93257-237a-43ac-b1ab-0905246fb60e2
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY59d93257-237a-43ac-b1ab-0905246fb60e2
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSYf8c0bc80-b34e-daa8-e053-6394a90a05c22
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN5fa0eda4-0886-415c-a30c-ae9729f169741
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN4e42a04a-ab8e-3ec9-e063-6394a90a45651
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN39fa4247-e864-f653-e063-6394a90ac98d1
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD5fa0eda4-0886-415c-a30c-ae9729f169741
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD4e42a04a-ab8e-3ec9-e063-6394a90a45651
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD39fa4247-e864-f653-e063-6394a90ac98d1
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY5fa0eda4-0886-415c-a30c-ae9729f169741
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY4e42a04a-ab8e-3ec9-e063-6394a90a45651
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY39fa4247-e864-f653-e063-6394a90ac98d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
27241-097-0527241009705500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-097-05) 2021-10-180000-00-00NoNoCurrent
27241-097-062724100970660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-097-06) 2017-03-160000-00-00NoNoCurrent
27241-097-10272410097101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-097-10) 2017-03-160000-00-00NoNoCurrent
27241-097-902724100979090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-097-90) 2021-10-180000-00-00NoNoCurrent