FDA.reportPublic FDA data

Duloxetine

Product NDC
71335-0402
11-digit product format
713350402
Labeler code
71335
Product ID
71335-0402_fffa451d-800b-4e92-a01c-5a174e6e32b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208706
Marketing category
ANDA
Marketing start
2017-03-16
Substance
DULOXETINE HYDROCHLORIDE
Active strength
60 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 HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596934

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
71335-0402-1Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE3012
71335-0402-2Duloxetine28 in 1 BOTTLECAPSULE, DELAYED RELEASE2812
71335-0402-3Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE6012
71335-0402-4Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE9012
71335-0402-5Duloxetine180 in 1 BOTTLECAPSULE, DELAYED RELEASE18012
71335-0402-6Duloxetine120 in 1 BOTTLECAPSULE, DELAYED RELEASE12012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0402-1EA - Each71335-040204e3dd41-021b-4e0e-9bf3-9dcdd3d1d6a212018-04-19
71335-0402-3EA - Each71335-04020a21fa78-a6bc-49e6-bbd0-c6e983514dcb12018-05-09
71335-0402-4EA - Each71335-04029e0d5167-0d2a-4096-ab79-59031cfb607f12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0402DULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]12Current NDC, Legacy NDC, 6 package rows20240822_b19ba26f-4711-443e-83cf-5af7bb43a0a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNb19ba26f-4711-443e-83cf-5af7bb43a0a012
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDb19ba26f-4711-443e-83cf-5af7bb43a0a012
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYb19ba26f-4711-443e-83cf-5af7bb43a0a012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0402-17133504020130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0402-1) 2018-03-020000-00-00NoNoCurrent
71335-0402-27133504020228 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0402-2) 2021-12-270000-00-00NoNoCurrent
71335-0402-37133504020360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0402-3) 2018-04-110000-00-00NoNoCurrent
71335-0402-47133504020490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0402-4) 2018-10-300000-00-00NoNoCurrent
71335-0402-571335040205180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0402-5) 2018-11-120000-00-00NoNoCurrent
71335-0402-671335040206120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0402-6) 2021-12-270000-00-00NoNoCurrent