FDA.reportPublic FDA data

Duloxetine

Product NDC
68001-595
11-digit product format
680010595
Labeler code
68001
Product ID
68001-595_3cc7677d-d409-c32e-e063-6294a90a94f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA208706
Marketing category
ANDA
Marketing start
2023-07-28
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
Rxcui596926, 596930, 596934, 616402

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-595-04Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE305
68001-595-05Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE905
68001-595-08Duloxetine1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-595-04EA - Each68001-595c6a58d29-92a1-4ace-a416-2ddd8f6cc3bc12023-09-05
68001-595-05EA - Each68001-595625ec3e2-2ef5-4338-9213-ce5e29a970a312023-09-05
68001-595-08EA - Each68001-595d071cbbd-2b26-45ef-bea2-8c0f34e6b46212023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-595DULOXETINE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]4Current NDC, 3 package rows20240403_1409fc2b-7252-472f-b719-e56141b36da2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN1409fc2b-7252-472f-b719-e56141b36da25
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN1409fc2b-7252-472f-b719-e56141b36da25
616402DULoxetine 40 MG Delayed Release Oral CapsulePSN1409fc2b-7252-472f-b719-e56141b36da25
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN1409fc2b-7252-472f-b719-e56141b36da25
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD1409fc2b-7252-472f-b719-e56141b36da25
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD1409fc2b-7252-472f-b719-e56141b36da25
616402duloxetine 40 MG Delayed Release Oral CapsuleSCD1409fc2b-7252-472f-b719-e56141b36da25
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD1409fc2b-7252-472f-b719-e56141b36da25
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY1409fc2b-7252-472f-b719-e56141b36da25
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY1409fc2b-7252-472f-b719-e56141b36da25
616402duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral CapsuleSY1409fc2b-7252-472f-b719-e56141b36da25
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY1409fc2b-7252-472f-b719-e56141b36da25
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN2d942e38-90d4-de39-e063-6294a90a98221
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD2d942e38-90d4-de39-e063-6294a90a98221
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY2d942e38-90d4-de39-e063-6294a90a98221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68001-595-046800105950430 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-595-04) 2024-02-22NoNoCurrent
68001-595-056800105950590 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-595-05) 2023-11-10NoNoCurrent
68001-595-08680010595081000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-595-08) 2023-07-28NoNoCurrent