FDA.reportPublic FDA data

Duloxetine

Product NDC
68788-7672
11-digit product format
687887672
Labeler code
68788
Product ID
68788-7672_707ee23e-19a5-4e39-be4d-e262442a34a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA208706
Marketing category
ANDA
Marketing start
2020-02-28
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
68788-7672-0Duloxetine6 in 1 BOTTLECAPSULE, DELAYED RELEASE66
68788-7672-1Duloxetine10 in 1 BOTTLECAPSULE, DELAYED RELEASE106
68788-7672-2Duloxetine20 in 1 BOTTLECAPSULE, DELAYED RELEASE206
68788-7672-3Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE306
68788-7672-6Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE606
68788-7672-8Duloxetine100 in 1 BOTTLECAPSULE, DELAYED RELEASE1006
68788-7672-9Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7672-0EA - Each68788-7672fdf116f3-5c0f-4921-8723-02001309b39012020-05-08
68788-7672-1EA - Each68788-767275d5feb4-1f2c-4fae-857a-eb6ea82659ee12020-05-08
68788-7672-2EA - Each68788-7672b6763bad-e49d-4819-9e9e-ff922707f35212020-05-08
68788-7672-3EA - Each68788-7672d8f4da66-9415-46e7-b149-63760b21de8812020-05-08
68788-7672-6EA - Each68788-76723f8d91ae-908f-41ca-bd40-b029f56ac6e512020-05-08
68788-7672-8EA - Each68788-76728a3d0259-3a0d-4b39-8a16-87d5c2ecfff712020-05-08
68788-7672-9EA - Each68788-76728f5b116c-dc1b-4b5a-8b62-f6e1267dd13112020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7672DULOXETINE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 7 package rows20250406_7a7c67be-6800-4ec3-9072-1e0e390a854b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN7a7c67be-6800-4ec3-9072-1e0e390a854b6
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD7a7c67be-6800-4ec3-9072-1e0e390a854b6
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY7a7c67be-6800-4ec3-9072-1e0e390a854b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7672-0687887672006 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-0) 2020-02-280000-00-00NoNoCurrent
68788-7672-16878876720110 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-1) 2020-02-280000-00-00NoNoCurrent
68788-7672-26878876720220 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-2) 2020-02-280000-00-00NoNoCurrent
68788-7672-36878876720330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-3) 2020-02-280000-00-00NoNoCurrent
68788-7672-66878876720660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-6) 2020-02-280000-00-00NoNoCurrent
68788-7672-868788767208100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-8) 2020-02-280000-00-00NoNoCurrent
68788-7672-96878876720990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-9) 2020-02-280000-00-00NoNoCurrent