FDA.reportPublic FDA data

Duloxetine

Product NDC
71335-2567
11-digit product format
713352567
Labeler code
71335
Product ID
71335-2567_315c294c-23fa-4a48-be29-b8dea6781255
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090694
Marketing category
ANDA
Marketing start
2013-12-11
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Duloxetine
Listing expiration
2027-12-31

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
71335-2567-1Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE302
71335-2567-2Duloxetine28 in 1 BOTTLECAPSULE, DELAYED RELEASE282
71335-2567-3Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE602
71335-2567-4Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE902
71335-2567-5Duloxetine180 in 1 BOTTLECAPSULE, DELAYED RELEASE1802
71335-2567-6Duloxetine120 in 1 BOTTLECAPSULE, DELAYED RELEASE1202
71335-2567-7Duloxetine100 in 1 BOTTLECAPSULE, DELAYED RELEASE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2567-1EA - Each71335-256724413bc9-7618-4a7f-b0e3-a487015e26f512025-05-14
71335-2567-3EA - Each71335-25678b142943-8e6d-48ed-bee0-31056cffc14912025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2567DULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1Current NDC, 7 package rows20250207_c877bb68-759f-4d45-8bef-872554da4551.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNc877bb68-759f-4d45-8bef-872554da45512
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDc877bb68-759f-4d45-8bef-872554da45512
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYc877bb68-759f-4d45-8bef-872554da45512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2567-17133525670130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2567-1) 2025-02-05NoNoHistorical
71335-2567-27133525670228 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2567-2) 2025-02-05NoNoHistorical
71335-2567-37133525670360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2567-3) 2025-02-05NoNoHistorical
71335-2567-47133525670490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2567-4) 2025-02-05NoNoHistorical
71335-2567-571335256705180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2567-5) 2025-02-05NoNoHistorical
71335-2567-671335256706120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2567-6) 2025-02-05NoNoHistorical
71335-2567-771335256707100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2567-7) 2025-02-05NoNoHistorical