FDA.reportPublic FDA data

Duloxetine

Product NDC
76420-636
11-digit product format
764200636
Labeler code
76420
Product ID
76420-636_31e2603c-b629-1f0d-e063-6294a90a3646
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA208706
Marketing category
ANDA
Marketing start
2019-03-25
Substance
DULOXETINE HYDROCHLORIDE
Active strength
40 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 HYDROCHLORIDE40 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
76420-636-01Duloxetine100 in 1 BOTTLECAPSULE, DELAYED RELEASE1004
76420-636-20Duloxetine20 in 1 BOTTLECAPSULE, DELAYED RELEASE204
76420-636-30Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE304
76420-636-60Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE604
76420-636-90Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-636DULOXETINE (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE CAPSULE, DELAYED RELEASE [ASCLEMED USA, INC.]4Current NDC, 5 package rows20250408_f61bd9f3-cd3d-4c76-a110-0f1dcba610af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
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 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76420-636-0176420063601100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-636-01) 2023-10-17NoNoHistorical
76420-636-207642006362020 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-636-20) 2025-04-03NoNoHistorical
76420-636-307642006363030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-636-30) 2023-10-17NoNoHistorical
76420-636-607642006366060 in 1 BOTTLEHistorical
76420-636-907642006369090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-636-90) 2023-10-17NoNoHistorical