FDA.reportPublic FDA data

Duloxetine

Product NDC
72162-1599
11-digit product format
721621599
Labeler code
72162
Product ID
72162-1599_7a0ab4db-866d-4ff1-82d7-9616b57409bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203088
Marketing category
ANDA
Marketing start
2014-06-11
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
Brand name suffix
Delayed-Release
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
72162-1599-1Duloxetine Delayed-Release100 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS100102
72162-1599-9Duloxetine Delayed-Release90 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1599-1EA - Each72162-15997e58321d-8514-442a-a4d2-b2803d17b63012024-08-12
72162-1599-9EA - Each72162-1599530b0442-1337-4a06-b86b-4931927a0ad512024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1599DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]102Current NDC, 2 package rows20250403_a23e79b3-7bd3-4b83-beb0-dc23d4830e9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNa23e79b3-7bd3-4b83-beb0-dc23d4830e9e102
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDa23e79b3-7bd3-4b83-beb0-dc23d4830e9e102
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYa23e79b3-7bd3-4b83-beb0-dc23d4830e9e102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1599-172162159901100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (72162-1599-1) 2024-02-05NoNoHistorical
72162-1599-97216215990990 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (72162-1599-9) 2024-02-05NoNoHistorical