FDA.reportPublic FDA data

Duloxetine

Product NDC
71205-445
11-digit product format
712050445
Labeler code
71205
Product ID
71205-445_d0a48dfd-af34-470b-9e1f-7678203e9ae5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
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
71205-445-30Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
71205-445-60Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE601
71205-445-90Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-445-30EA - Each71205-445304d0ab3-c4ae-42f5-9fdb-f950b1b3710712020-08-06
71205-445-60EA - Each71205-44533ab323d-6e1a-4aea-8929-617d69069d6d12020-08-06
71205-445-90EA - Each71205-445e7d83031-98df-40c1-af9d-239752dacf5312021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-445DULOXETINE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1Current NDC, Legacy NDC, 3 package rows20200523_d0a48dfd-af34-470b-9e1f-7678203e9ae5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNd0a48dfd-af34-470b-9e1f-7678203e9ae51
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDd0a48dfd-af34-470b-9e1f-7678203e9ae51
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYd0a48dfd-af34-470b-9e1f-7678203e9ae51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-445-307120504453030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-445-30) 2020-05-190000-00-00NoNoCurrent
71205-445-607120504456060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-445-60) 2020-05-190000-00-00NoNoCurrent
71205-445-907120504459090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-445-90) 2020-05-190000-00-00NoNoCurrent