FDA.reportPublic FDA data

DULOXETINE

Product NDC
71335-1964
11-digit product format
713351964
Labeler code
71335
Product ID
71335-1964_b4aff1e4-f7f7-4929-92fd-6c27babc38f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206653
Marketing category
ANDA
Marketing start
2016-01-20
Substance
DULOXETINE HYDROCHLORIDE
Active strength
20 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 HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596926

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1964-1DULOXETINE30 in 1 BOTTLECAPSULE, DELAYED RELEASE30102
71335-1964-2DULOXETINE60 in 1 BOTTLECAPSULE, DELAYED RELEASE60102
71335-1964-3DULOXETINE28 in 1 BOTTLECAPSULE, DELAYED RELEASE28102
71335-1964-4DULOXETINE90 in 1 BOTTLECAPSULE, DELAYED RELEASE90102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1964DULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 4 package rows20240504_9a8cb289-0332-4835-960f-32d273092d15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN9a8cb289-0332-4835-960f-32d273092d15102
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD9a8cb289-0332-4835-960f-32d273092d15102
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY9a8cb289-0332-4835-960f-32d273092d15102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1964-17133519640130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1964-1) 2021-02-100000-00-00NoNoCurrent
71335-1964-27133519640260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1964-2) 2021-02-100000-00-00NoNoCurrent
71335-1964-37133519640328 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1964-3) 2021-02-100000-00-00NoNoCurrent
71335-1964-47133519640490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1964-4) 2021-02-100000-00-00NoNoCurrent