FDA.reportPublic FDA data

Duloxetine

Product NDC
63629-9187
11-digit product format
636299187
Labeler code
63629
Product ID
63629-9187_f5305d0f-4cbb-4e42-baef-01ed0f71915c
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
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
63629-9187-1Duloxetine Delayed-Release30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS30103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9187-1EA - Each63629-9187a292888a-9823-400f-be12-e66867ecefc512022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9187DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20250331_c934cc41-b40b-4c5c-b019-a749eec52d88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616402DULoxetine 40 MG Delayed Release Oral CapsulePSNc934cc41-b40b-4c5c-b019-a749eec52d88103
616402duloxetine 40 MG Delayed Release Oral CapsuleSCDc934cc41-b40b-4c5c-b019-a749eec52d88103
616402duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral CapsuleSYc934cc41-b40b-4c5c-b019-a749eec52d88103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-9187-16362991870130 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63629-9187-1) 2022-08-030000-00-00NoNoCurrent