FDA.reportPublic FDA data

Duloxetine

Product NDC
71205-358
11-digit product format
712050358
Labeler code
71205
Product ID
71205-358_5761ba46-a046-4deb-93b9-87919fbc17d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
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
71205-358-30Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE302
71205-358-60Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE602
71205-358-90Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-358-30EA - Each71205-35864600198-5860-44e2-bc79-4ac100c1533912020-03-10
71205-358-60EA - Each71205-358f5ab9903-fdec-41b3-9ce2-117b3864a4c812020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-358DULOXETINE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220728_e36a6919-568a-4d4a-9920-7a7fe4f3441c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNe36a6919-568a-4d4a-9920-7a7fe4f3441c2
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDe36a6919-568a-4d4a-9920-7a7fe4f3441c2
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYe36a6919-568a-4d4a-9920-7a7fe4f3441c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-358-307120503583030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-358-30) 2019-11-140000-00-00NoNoCurrent
71205-358-607120503586060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-358-60) 2019-11-140000-00-00NoNoCurrent
71205-358-907120503589090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-358-90) 2019-11-140000-00-00NoNoCurrent