FDA.reportPublic FDA data

Duloxetine

Product NDC
27241-098
11-digit product format
272410098
Labeler code
27241
Product ID
27241-098_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
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
2026-12-31

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
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
27241-098-03Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE3018
27241-098-09Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE9018
27241-098-10Duloxetine1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-098-03EA - Each27241-098aed9760c-5485-4d83-9c0e-d90bc07392a112017-09-11
27241-098-09EA - Each27241-098fce075a1-6f56-4e83-ba48-d82a815b37bb12017-09-11
27241-098-10EA - Each27241-098e01a7676-b455-4b72-a0c4-2a30fae6ac3f12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-098DULOXETINE CAPSULE, DELAYED RELEASE [AJANTA PHARMA USA INC.]16Current NDC, Legacy NDC, 3 package rows20230908_2dde979d-b6f8-41d1-96fb-325c75ea3a74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN3fbdcc34-6166-4843-839c-33fed718ffb2103
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD3fbdcc34-6166-4843-839c-33fed718ffb2103
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY3fbdcc34-6166-4843-839c-33fed718ffb2103
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNb149641a-03e6-4fee-91f3-7ba8e01196bd22
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDb149641a-03e6-4fee-91f3-7ba8e01196bd22
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYb149641a-03e6-4fee-91f3-7ba8e01196bd22
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
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNed164dbb-e713-42d1-a78e-31145578b9f812
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDed164dbb-e713-42d1-a78e-31145578b9f812
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYed164dbb-e713-42d1-a78e-31145578b9f812
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNc4fa1d3b-f136-e14f-e053-2a95a90a6cfb9
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDc4fa1d3b-f136-e14f-e053-2a95a90a6cfb9
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYc4fa1d3b-f136-e14f-e053-2a95a90a6cfb9
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN556d7dd0-0e3d-4f70-9786-e546a43ef5398
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN556d7dd0-0e3d-4f70-9786-e546a43ef5398
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD556d7dd0-0e3d-4f70-9786-e546a43ef5398
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD556d7dd0-0e3d-4f70-9786-e546a43ef5398
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY556d7dd0-0e3d-4f70-9786-e546a43ef5398
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY556d7dd0-0e3d-4f70-9786-e546a43ef5398
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN9221aea1-8de1-b94e-e053-2a95a90a1eae7
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD9221aea1-8de1-b94e-e053-2a95a90a1eae7
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY9221aea1-8de1-b94e-e053-2a95a90a1eae7
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNe86eb765-ac9c-4ed9-bce8-8191515593946
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDe86eb765-ac9c-4ed9-bce8-8191515593946
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYe86eb765-ac9c-4ed9-bce8-8191515593946
596926DULoxetine 20 MG Delayed Release Oral CapsulePSNf61bd9f3-cd3d-4c76-a110-0f1dcba610af4
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN6b1cac95-83e3-4fad-8d60-7a1a9e675eb24
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNb6040e79-0bbd-41a3-ba86-2a360a41864c4
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
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD6b1cac95-83e3-4fad-8d60-7a1a9e675eb24
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDf61bd9f3-cd3d-4c76-a110-0f1dcba610af4
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDb6040e79-0bbd-41a3-ba86-2a360a41864c4
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 CapsuleSYf61bd9f3-cd3d-4c76-a110-0f1dcba610af4
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYf61bd9f3-cd3d-4c76-a110-0f1dcba610af4
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY6b1cac95-83e3-4fad-8d60-7a1a9e675eb24
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYb6040e79-0bbd-41a3-ba86-2a360a41864c4
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
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN2425f770-a264-4aec-9439-7c2dbd2da5483
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN2425f770-a264-4aec-9439-7c2dbd2da5483
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD2425f770-a264-4aec-9439-7c2dbd2da5483
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD2425f770-a264-4aec-9439-7c2dbd2da5483
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY2425f770-a264-4aec-9439-7c2dbd2da5483
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY2425f770-a264-4aec-9439-7c2dbd2da5483
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN4a66fde2-4cce-b92e-e063-6294a90a63ee2
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN39bb9e78-e550-4bf9-ba6a-b4d9c7beaeb72
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD39bb9e78-e550-4bf9-ba6a-b4d9c7beaeb72
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD4a66fde2-4cce-b92e-e063-6294a90a63ee2
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY4a66fde2-4cce-b92e-e063-6294a90a63ee2
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY39bb9e78-e550-4bf9-ba6a-b4d9c7beaeb72
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN2b61c261-d7f2-4f9d-e063-6294a90acc241
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN4121bd3f-2d6d-3bdd-e063-6294a90a30881
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD2b61c261-d7f2-4f9d-e063-6294a90acc241
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD4121bd3f-2d6d-3bdd-e063-6294a90a30881
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY2b61c261-d7f2-4f9d-e063-6294a90acc241
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY4121bd3f-2d6d-3bdd-e063-6294a90a30881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
27241-098-032724100980330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-098-03) 2017-03-160000-00-00NoNoCurrent
27241-098-092724100980990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-098-09) 2017-03-160000-00-00NoNoCurrent
27241-098-10272410098101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-098-10) 2017-03-160000-00-00NoNoCurrent