FDA.reportPublic FDA data

Duloxetine

Product NDC
76420-236
11-digit product format
764200236
Labeler code
76420
Product ID
76420-236_e347f58a-9f2f-7e64-e053-2a95a90a528b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA090776
Marketing category
ANDA
Marketing start
2013-12-17
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
Rxcui596930

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
76420-236-30Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS301
76420-236-60Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS601
76420-236-90Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-236-30EA - Each76420-236007126b7-36fe-4f88-a3ad-989e7b52414912022-08-04
76420-236-60EA - Each76420-2368890df9d-dd98-4f60-aa0b-35b8ab38aa9012022-08-04
76420-236-90EA - Each76420-236d8e3bbcd-bc3b-4fda-b662-36548ea013fb12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-236DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [ASCLEMED USA, INC.]1Current NDC, Legacy NDC, 3 package rows20220710_7c755ca3-0855-4b54-80a8-01b85f8e644a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN7c755ca3-0855-4b54-80a8-01b85f8e644a1
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD7c755ca3-0855-4b54-80a8-01b85f8e644a1
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY7c755ca3-0855-4b54-80a8-01b85f8e644a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76420-236-307642002363030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (76420-236-30) 2022-07-070000-00-00NoNoCurrent
76420-236-607642002366060 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (76420-236-60) 2022-07-070000-00-00NoNoCurrent
76420-236-907642002369090 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (76420-236-90) 2022-07-070000-00-00NoNoCurrent