FDA.reportPublic FDA data

Duloxetine

Product NDC
71335-2017
11-digit product format
713352017
Labeler code
71335
Product ID
71335-2017_5bbd5576-705f-420f-80e0-a72d8e43c42f
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
30 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 HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596930

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2017-1Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE30103
71335-2017-2Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE60103
71335-2017-3Duloxetine28 in 1 BOTTLECAPSULE, DELAYED RELEASE28103
71335-2017-4Duloxetine6 in 1 BOTTLECAPSULE, DELAYED RELEASE6103
71335-2017-5Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE90103
71335-2017-6Duloxetine15 in 1 BOTTLECAPSULE, DELAYED RELEASE15103
71335-2017-7Duloxetine180 in 1 BOTTLECAPSULE, DELAYED RELEASE180103
71335-2017-8Duloxetine120 in 1 BOTTLECAPSULE, DELAYED RELEASE120103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2017-1EA - Each71335-20173f5dfd0a-cd69-4d2b-a34e-501f720277b812022-07-06
71335-2017-2EA - Each71335-201738d7a0a6-5a3d-4c83-8c22-5ee1ee19f29e12022-05-04
71335-2017-5EA - Each71335-201754c5bc24-17fb-4263-8e34-131d0f5dc8a612023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2017DULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 8 package rows20240809_3fbdcc34-6166-4843-839c-33fed718ffb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN3fbdcc34-6166-4843-839c-33fed718ffb2103
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD3fbdcc34-6166-4843-839c-33fed718ffb2103
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY3fbdcc34-6166-4843-839c-33fed718ffb2103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2017-17133520170130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2017-1) 2022-02-100000-00-00NoNoCurrent
71335-2017-27133520170260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2017-2) 2022-02-100000-00-00NoNoCurrent
71335-2017-37133520170328 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2017-3) 2022-02-100000-00-00NoNoCurrent
71335-2017-4713352017046 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2017-4) 2022-02-100000-00-00NoNoCurrent
71335-2017-57133520170590 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2017-5) 2022-02-100000-00-00NoNoCurrent
71335-2017-67133520170615 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2017-6) 2022-02-100000-00-00NoNoCurrent
71335-2017-771335201707180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2017-7) 2022-02-100000-00-00NoNoCurrent
71335-2017-871335201708120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2017-8) 2022-02-100000-00-00NoNoCurrent