FDA.reportPublic FDA data

Duloxetine

Product NDC
63629-1991
11-digit product format
636291991
Labeler code
63629
Product ID
63629-1991_d5e81e01-e04b-4d91-b29e-96a346636a01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203088
Marketing category
ANDA
Marketing start
2014-06-11
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
Brand name suffix
Delayed-Release
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
63629-1991-1Duloxetine Delayed-Release90 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS90105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1991-1EA - Each63629-1991a6576159-88ba-439f-9517-9b9225e5673a12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1991DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 1 package rows20250322_ca36f94c-2215-436f-ada8-7319f4f3e054.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNca36f94c-2215-436f-ada8-7319f4f3e054105
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDca36f94c-2215-436f-ada8-7319f4f3e054105
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYca36f94c-2215-436f-ada8-7319f4f3e054105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1991-16362919910190 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63629-1991-1) 2014-06-110000-00-00NoNoCurrent