FDA.reportPublic FDA data

Duloxetine Hydrochloride

Product NDC
46708-128
11-digit product format
467080128
Labeler code
46708
Product ID
46708-128_53df64fc-7fec-4c14-8fe3-c6a128be814a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA202949
Marketing category
ANDA
Marketing start
2014-06-09
Marketing end
0000-00-00
Substance
DULOXETINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46708-128-102020-01-31C16284748780-19d75b9d0-f7cf-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use duloxetine delayed-release capsules safely and effectively. See full prescribing information for duloxetine delayed-release capsules. DULOXETINE delayed-release capsules for oral use. Initial U.S. Approval: 2004
46708-128-302020-01-31C16284748780-19d75b9d0-f7cf-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use duloxetine delayed-release capsules safely and effectively. See full prescribing information for duloxetine delayed-release capsules. DULOXETINE delayed-release capsules for oral use. Initial U.S. Approval: 2004
46708-128-602020-01-31C16284748780-19d75b9d0-f7cf-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use duloxetine delayed-release capsules safely and effectively. See full prescribing information for duloxetine delayed-release capsules. DULOXETINE delayed-release capsules for oral use. Initial U.S. Approval: 2004
46708-128-912020-01-31C16284748780-19d75b9d0-f7cf-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use duloxetine delayed-release capsules safely and effectively. See full prescribing information for duloxetine delayed-release capsules. DULOXETINE delayed-release capsules for oral use. Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-128-10Duloxetine Hydrochloride20 mg100 in 1 CARTONCAPSULE, DELAYED RELEASE1001
46708-128-30Duloxetine Hydrochloride20 mg30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
46708-128-60Duloxetine Hydrochloride20 mg60 in 1 BOTTLECAPSULE, DELAYED RELEASE601
46708-128-91Duloxetine Hydrochloride20 mg1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]1
DULOXETINEACTIVE MOIETYO5TNM5N07UDULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XDULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]1
GELATININACTIVE INGREDIENT2G86QN327LDULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]1
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)INACTIVE INGREDIENTG4U024CQK6DULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TDULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]1
SHELLACINACTIVE INGREDIENT46N107B71ODULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]1
SUCROSEINACTIVE INGREDIENTC151H8M554DULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-128DULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]1Legacy NDC, 4 package rows20140620_53df64fc-7fec-4c14-8fe3-c6a128be814a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN53df64fc-7fec-4c14-8fe3-c6a128be814a1
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN53df64fc-7fec-4c14-8fe3-c6a128be814a1
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN53df64fc-7fec-4c14-8fe3-c6a128be814a1
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD53df64fc-7fec-4c14-8fe3-c6a128be814a1
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD53df64fc-7fec-4c14-8fe3-c6a128be814a1
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD53df64fc-7fec-4c14-8fe3-c6a128be814a1
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY53df64fc-7fec-4c14-8fe3-c6a128be814a1
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY53df64fc-7fec-4c14-8fe3-c6a128be814a1
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY53df64fc-7fec-4c14-8fe3-c6a128be814a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
46708-128-1046708012810100 in 1 CARTONHistorical
46708-128-304670801283030 in 1 BOTTLEHistorical
46708-128-604670801286060 in 1 BOTTLEHistorical
46708-128-91467080128911000 in 1 BOTTLEHistorical