FDA.reportPublic FDA data

DULOXETINE HYDROCHLORIDE

Product NDC
62332-278
11-digit product format
623320278
Labeler code
62332
Product ID
62332-278_68db1bf0-65d7-4c3a-94ec-79209242a3d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA202949
Marketing category
ANDA
Marketing start
2026-04-09
Substance
DULOXETINE HYDROCHLORIDE
Active strength
20 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DULOXETINE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULOXETINE HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596926, 596930, 596934

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-278-30DULOXETINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE, DELAYED RELEASE303
62332-278-60DULOXETINE HYDROCHLORIDE60 in 1 BOTTLECAPSULE, DELAYED RELEASE603
62332-278-90DULOXETINE HYDROCHLORIDE90 in 1 BOTTLECAPSULE, DELAYED RELEASE903
62332-278-91DULOXETINE HYDROCHLORIDE1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN39453971-766d-45bf-a0fd-4658d72bae723
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN39453971-766d-45bf-a0fd-4658d72bae723
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN39453971-766d-45bf-a0fd-4658d72bae723
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD39453971-766d-45bf-a0fd-4658d72bae723
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD39453971-766d-45bf-a0fd-4658d72bae723
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD39453971-766d-45bf-a0fd-4658d72bae723
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY39453971-766d-45bf-a0fd-4658d72bae723
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY39453971-766d-45bf-a0fd-4658d72bae723
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY39453971-766d-45bf-a0fd-4658d72bae723

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62332-278-306233202783030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62332-278-30) 2026-04-09NoNoCurrent
62332-278-606233202786060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62332-278-60) 2026-04-09NoNoCurrent
62332-278-906233202789090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62332-278-90) 2026-04-09NoNoCurrent
62332-278-91623320278911000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62332-278-91) 2026-04-09NoNoCurrent