FDA.reportPublic FDA data

Duloxetine

Product NDC
27241-099
11-digit product format
272410099
Labeler code
27241
Product ID
27241-099_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
60 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 HYDROCHLORIDE60 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27241-099-03Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE3018
27241-099-40Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE9018
27241-099-90Duloxetine1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-099-03EA - Each27241-099523df9f6-dfdf-4495-bbd4-270114ea392d12017-09-11
27241-099-90EA - Each27241-099fe22229d-a2d7-46e5-80f2-2b9dd47b211912017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-099DULOXETINE 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
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNdb85a82d-84f1-41c8-964b-ac94ae4d8e7b20
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDdb85a82d-84f1-41c8-964b-ac94ae4d8e7b20
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYdb85a82d-84f1-41c8-964b-ac94ae4d8e7b20
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNba4adb77-45be-4310-a877-766692f22e5e19
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDba4adb77-45be-4310-a877-766692f22e5e19
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYba4adb77-45be-4310-a877-766692f22e5e19
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
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNac903bda-76af-4aba-9c8a-ebf7066e05ee15
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDac903bda-76af-4aba-9c8a-ebf7066e05ee15
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYac903bda-76af-4aba-9c8a-ebf7066e05ee15
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNb19ba26f-4711-443e-83cf-5af7bb43a0a012
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDb19ba26f-4711-443e-83cf-5af7bb43a0a012
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYb19ba26f-4711-443e-83cf-5af7bb43a0a012
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN556d7dd0-0e3d-4f70-9786-e546a43ef5398
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNb70035d4-5a3f-c5b5-e053-2995a90acac18
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 CapsuleSCDb70035d4-5a3f-c5b5-e053-2995a90acac18
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 CapsuleSYb70035d4-5a3f-c5b5-e053-2995a90acac18
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY556d7dd0-0e3d-4f70-9786-e546a43ef5398
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNfa5657a8-c6d9-474a-9d1a-b75b41b4327f7
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDfa5657a8-c6d9-474a-9d1a-b75b41b4327f7
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYfa5657a8-c6d9-474a-9d1a-b75b41b4327f7
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN7a7c67be-6800-4ec3-9072-1e0e390a854b6
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD7a7c67be-6800-4ec3-9072-1e0e390a854b6
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY7a7c67be-6800-4ec3-9072-1e0e390a854b6
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
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNc194a7b0-1e7e-a32b-e053-2995a90a7dbd4
596926duloxetine 20 MG Delayed Release Oral CapsuleSCDf61bd9f3-cd3d-4c76-a110-0f1dcba610af4
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
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDc194a7b0-1e7e-a32b-e053-2995a90a7dbd4
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 CapsuleSYc194a7b0-1e7e-a32b-e053-2995a90a7dbd4
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 CapsulePSN07a7dd8d-cbf8-4281-8583-d2d98711ed6c3
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN2425f770-a264-4aec-9439-7c2dbd2da5483
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN9221f3e5-17b8-ea74-e053-2a95a90ad1a83
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN075fc7c9-7b4b-b9c3-e063-6394a90a926e3
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD2425f770-a264-4aec-9439-7c2dbd2da5483
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD075fc7c9-7b4b-b9c3-e063-6394a90a926e3
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD9221f3e5-17b8-ea74-e053-2a95a90ad1a83
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD07a7dd8d-cbf8-4281-8583-d2d98711ed6c3
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 CapsuleSY07a7dd8d-cbf8-4281-8583-d2d98711ed6c3
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY2425f770-a264-4aec-9439-7c2dbd2da5483
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY075fc7c9-7b4b-b9c3-e063-6394a90a926e3
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY9221f3e5-17b8-ea74-e053-2a95a90ad1a83
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNe36a6919-568a-4d4a-9920-7a7fe4f3441c2
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNc482d64a-73dd-4af2-9b3c-efff47e7395c2
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDe36a6919-568a-4d4a-9920-7a7fe4f3441c2
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDc482d64a-73dd-4af2-9b3c-efff47e7395c2
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYe36a6919-568a-4d4a-9920-7a7fe4f3441c2
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYc482d64a-73dd-4af2-9b3c-efff47e7395c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
27241-099-032724100990330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-099-03) 2017-03-160000-00-00NoNoCurrent
27241-099-402724100994090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-099-40) 2021-10-180000-00-00NoNoCurrent
27241-099-90272410099901000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-099-90) 2017-03-160000-00-00NoNoCurrent