FDA.reportPublic FDA data

Duloxetine

Product NDC
71335-3062
11-digit product format
713353062
Labeler code
71335
Product ID
71335-3062_6e8eb894-3741-403a-bea4-bbee94778d21
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
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
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 HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596926

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
71335-3062-1Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
71335-3062-2Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE601
71335-3062-3Duloxetine28 in 1 BOTTLECAPSULE, DELAYED RELEASE281
71335-3062-4Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-3062-1EA - Each71335-306208f9fefd-eb59-4d71-a916-72e2ab210aa012026-05-22
71335-3062-2EA - Each71335-30622cd4abb2-d643-4683-8412-fad4dc8f5fe312026-05-22
71335-3062-3EA - Each71335-30625c820f79-0421-4d7c-a891-58805e11a96812026-05-22
71335-3062-4EA - Each71335-30626f806d32-6514-4aa5-a184-1e663412c7ff12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN5fa0eda4-0886-415c-a30c-ae9729f169741
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD5fa0eda4-0886-415c-a30c-ae9729f169741
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY5fa0eda4-0886-415c-a30c-ae9729f169741

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-3062-17133530620130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-3062-1) 2026-02-06NoNoHistorical
71335-3062-27133530620260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-3062-2) 2026-02-06NoNoHistorical
71335-3062-37133530620328 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-3062-3) 2026-02-06NoNoHistorical
71335-3062-47133530620490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-3062-4) 2026-02-06NoNoHistorical