FDA.reportPublic FDA data

Duloxetine

Product NDC
82804-024
11-digit product format
828040024
Labeler code
82804
Product ID
82804-024_f5e7503a-b28f-4cd0-a4ee-47bdca88d54b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203088
Marketing category
ANDA
Marketing start
2018-05-21
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
Brand name suffix
Delayed-Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULOXETINE HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui616402

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
82804-024-30DuloxetineDelayed-Release30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS301
82804-024-60DuloxetineDelayed-Release60 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS601
82804-024-90DuloxetineDelayed-Release90 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-024-30EA - Each82804-0245b79153a-5535-4a57-919c-aba151a656a312023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-024DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [PROFICIENT RX LP]1Current NDC, 3 package rows20231027_f5e7503a-b28f-4cd0-a4ee-47bdca88d54b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616402DULoxetine 40 MG Delayed Release Oral CapsulePSNf5e7503a-b28f-4cd0-a4ee-47bdca88d54b1
616402duloxetine 40 MG Delayed Release Oral CapsuleSCDf5e7503a-b28f-4cd0-a4ee-47bdca88d54b1
616402duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral CapsuleSYf5e7503a-b28f-4cd0-a4ee-47bdca88d54b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-024-308280400243030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82804-024-30) 2023-10-16NoNoCurrent
82804-024-608280400246060 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82804-024-60) 2023-10-16NoNoCurrent
82804-024-908280400249090 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82804-024-90) 2023-10-16NoNoCurrent