FDA.reportPublic FDA data

Duloxetine

Product NDC
71335-1672
11-digit product format
713351672
Labeler code
71335
Product ID
71335-1672_a5fa1183-35f7-41b9-8452-5d00ccd868a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203197
Marketing category
ANDA
Marketing start
2012-05-01
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
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1672-1Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE306
71335-1672-2Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE606
71335-1672-3Duloxetine28 in 1 BOTTLECAPSULE, DELAYED RELEASE286
71335-1672-4Duloxetine6 in 1 BOTTLECAPSULE, DELAYED RELEASE66
71335-1672-5Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE906
71335-1672-6Duloxetine15 in 1 BOTTLECAPSULE, DELAYED RELEASE156
71335-1672-7Duloxetine180 in 1 BOTTLECAPSULE, DELAYED RELEASE1806
71335-1672-8Duloxetine120 in 1 BOTTLECAPSULE, DELAYED RELEASE1206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1672-1EA - Each71335-1672c74b3b85-e5d8-4064-ad3e-2d16cfc4424f12021-02-05
71335-1672-2EA - Each71335-167267a083f5-1d6f-4e2d-8d39-06df451214f012021-02-05
71335-1672-5EA - Each71335-16721764c6dc-dc4b-40fb-b80c-6dd1a4df1d8312021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1672DULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 8 package rows20240410_c52fc4ad-7bda-4824-8edf-117d3d8d6b3d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNc52fc4ad-7bda-4824-8edf-117d3d8d6b3d6
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDc52fc4ad-7bda-4824-8edf-117d3d8d6b3d6
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYc52fc4ad-7bda-4824-8edf-117d3d8d6b3d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1672-17133516720130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-1) 2020-07-270000-00-00NoNoCurrent
71335-1672-27133516720260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-2) 2020-08-280000-00-00NoNoCurrent
71335-1672-37133516720328 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-3) 2024-04-040000-00-00NoNoCurrent
71335-1672-4713351672046 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-4) 2024-04-040000-00-00NoNoCurrent
71335-1672-57133516720590 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-5) 2020-12-220000-00-00NoNoCurrent
71335-1672-67133516720615 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-6) 2021-01-070000-00-00NoNoCurrent
71335-1672-771335167207180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-7) 2021-02-010000-00-00NoNoCurrent
71335-1672-871335167208120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-8) 2024-04-040000-00-00NoNoCurrent