FDA.reportPublic FDA data

Duloxetine

Product NDC
63629-5174
11-digit product format
636295174
Labeler code
63629
Product ID
63629-5174_d4a8f0e5-75a8-4116-ad00-97fa142a8ad1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090745
Marketing category
ANDA
Marketing start
2013-12-11
Marketing end
0000-00-00
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
2023-12-31
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
63629-5174-12024-01-30C16284748780-19855e2a2-3eb8-60a7-e053-dbdaa90a05bdThese 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
63629-5174-22024-01-30C16284748780-19855e2a2-3eb8-60a7-e053-dbdaa90a05bdThese 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
63629-5174-32024-01-30C16284748780-19855e2a2-3eb8-60a7-e053-dbdaa90a05bdThese 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
63629-5174-42024-01-30C16284748780-19855e2a2-3eb8-60a7-e053-dbdaa90a05bdThese 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
63629-5174-52024-01-30C16284748780-19855e2a2-3eb8-60a7-e053-dbdaa90a05bdThese 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
63629-5174-62024-01-30C16284748780-19855e2a2-3eb8-60a7-e053-dbdaa90a05bdThese 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
63629-5174-72024-01-30C16284748780-19855e2a2-3eb8-60a7-e053-dbdaa90a05bdThese 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
63629-5174-82024-01-30C16284748780-19855e2a2-3eb8-60a7-e053-dbdaa90a05bdThese 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
63629-5174-12022-02-16C16284748780-19855e2a2-3eb8-60a7-e053-dbdaa90a05bdThese 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
63629-5174-22022-02-16C16284748780-19855e2a2-3eb8-60a7-e053-dbdaa90a05bdThese 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
63629-5174-32022-02-16C16284748780-19855e2a2-3eb8-60a7-e053-dbdaa90a05bdThese 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
63629-5174-42022-02-16C16284748780-19855e2a2-3eb8-60a7-e053-dbdaa90a05bdThese 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
63629-5174-52022-02-16C16284748780-19855e2a2-3eb8-60a7-e053-dbdaa90a05bdThese 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
63629-5174-12019-11-27C16284748780-19855e2a2-3eb8-60a7-e053-dbdaa90a05bdThese 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
63629-5174-22019-11-27C16284748780-19855e2a2-3eb8-60a7-e053-dbdaa90a05bdThese 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
63629-5174-32019-11-27C16284748780-19855e2a2-3eb8-60a7-e053-dbdaa90a05bdThese 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
63629-5174-42019-11-27C16284748780-19855e2a2-3eb8-60a7-e053-dbdaa90a05bdThese 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
63629-5174-52019-11-27C16284748780-19855e2a2-3eb8-60a7-e053-dbdaa90a05bdThese 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
63629-5174-1Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE301001
63629-5174-2Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE601001
63629-5174-3Duloxetine28 in 1 BOTTLECAPSULE, DELAYED RELEASE281001
63629-5174-4Duloxetine6 in 1 BOTTLECAPSULE, DELAYED RELEASE61001
63629-5174-5Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE901001
63629-5174-6Duloxetine15 in 1 BOTTLECAPSULE, DELAYED RELEASE151001
63629-5174-7Duloxetine180 in 1 BOTTLECAPSULE, DELAYED RELEASE1801001
63629-5174-8Duloxetine120 in 1 BOTTLECAPSULE, DELAYED RELEASE1201001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-5174-1EA - Each63629-5174c83ce80c-688f-4379-a4c3-9c5774630ce412016-03-04
63629-5174-2EA - Each63629-517444599fc9-d022-444c-9286-25250605c23312016-01-13
63629-5174-3EA - Each63629-5174a66db0ee-2331-4082-8dc3-055b5838d91012016-03-04
63629-5174-4EA - Each63629-51746401b5b8-f34e-4288-b827-41a5a1433d5212016-03-04
63629-5174-5EA - Each63629-5174c47ecaec-421f-4567-ae33-a8148f986aa012016-03-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
DULOXETINEACTIVE MOIETYO5TNM5N07UDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
ALCOHOLINACTIVE INGREDIENT3K9958V90MDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
AMMONIAINACTIVE INGREDIENT5138Q19F1XDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
GELATININACTIVE INGREDIENT2G86QN327LDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
MANNITOLINACTIVE INGREDIENT3OWL53L36ADULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
SHELLACINACTIVE INGREDIENT46N107B71ODULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
SUCROSEINACTIVE INGREDIENTC151H8M554DULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1UDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
WATERINACTIVE INGREDIENT059QF0KO0RDULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5174DULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1001Legacy NDC, 8 package rows20220217_d4a8f0e5-75a8-4116-ad00-97fa142a8ad1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNd4a8f0e5-75a8-4116-ad00-97fa142a8ad11001
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDd4a8f0e5-75a8-4116-ad00-97fa142a8ad11001
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYd4a8f0e5-75a8-4116-ad00-97fa142a8ad11001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-5174-16362951740130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-5174-1) 2014-01-060000-00-00NoNoCurrent
63629-5174-26362951740260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-5174-2) 2014-02-210000-00-00NoNoCurrent
63629-5174-36362951740328 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-5174-3) 2014-02-070000-00-00NoNoCurrent
63629-5174-4636295174046 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-5174-4) 2014-10-310000-00-00NoNoCurrent
63629-5174-56362951740590 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-5174-5) 2015-02-250000-00-00NoNoCurrent
63629-5174-66362951740615 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-5174-6) 2022-02-150000-00-00NoNoCurrent
63629-5174-763629517407180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-5174-7) 2022-02-150000-00-00NoNoCurrent
63629-5174-863629517408120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-5174-8) 2022-02-150000-00-00NoNoCurrent