FDA.reportPublic FDA data

duloxetine

Product NDC
49252-008
11-digit product format
492520008
Labeler code
49252
Product ID
49252-008_3fb45d3e-3fbc-8814-e063-6294a90a4a70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Inventia Healthcare Limited.
Application
ANDA202336
Marketing category
ANDA
Marketing start
2015-12-05
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
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 HYDROCHLORIDE30 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49252-008-102021-12-09C16284748780-19d75b9d0-43b4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DULOXETINE DELAYED RELEASE CAPSULES, USP safely and effectively. See full prescribing information for DULOXETINE DELAYED RELEASE CAPSULES, USP. DULOXETINE delayed-release capsules, for oral use. Initial U.S. Approval:2004
49252-008-112021-12-09C16284748780-19d75b9d0-43b4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DULOXETINE DELAYED RELEASE CAPSULES, USP safely and effectively. See full prescribing information for DULOXETINE DELAYED RELEASE CAPSULES, USP. DULOXETINE delayed-release capsules, for oral use. Initial U.S. Approval:2004
49252-008-122021-12-09C16284748780-19d75b9d0-43b4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DULOXETINE DELAYED RELEASE CAPSULES, USP safely and effectively. See full prescribing information for DULOXETINE DELAYED RELEASE CAPSULES, USP. DULOXETINE delayed-release capsules, for oral use. Initial U.S. Approval:2004
49252-008-182021-12-09C16284748780-19d75b9d0-43b4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DULOXETINE DELAYED RELEASE CAPSULES, USP safely and effectively. See full prescribing information for DULOXETINE DELAYED RELEASE CAPSULES, USP. DULOXETINE delayed-release capsules, for oral use. Initial U.S. Approval:2004
49252-008-572021-12-09C16284748780-19d75b9d0-43b4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DULOXETINE DELAYED RELEASE CAPSULES, USP safely and effectively. See full prescribing information for DULOXETINE DELAYED RELEASE CAPSULES, USP. DULOXETINE delayed-release capsules, for oral use. Initial U.S. Approval:2004
49252-008-102020-01-31C16284748780-19d75b9d0-43b4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DULOXETINE DELAYED RELEASE CAPSULES, USP safely and effectively. See full prescribing information for DULOXETINE DELAYED RELEASE CAPSULES, USP. DULOXETINE delayed-release capsules, for oral use. Initial U.S. Approval:2004
49252-008-112020-01-31C16284748780-19d75b9d0-43b4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DULOXETINE DELAYED RELEASE CAPSULES, USP safely and effectively. See full prescribing information for DULOXETINE DELAYED RELEASE CAPSULES, USP. DULOXETINE delayed-release capsules, for oral use. Initial U.S. Approval:2004
49252-008-122020-01-31C16284748780-19d75b9d0-43b4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DULOXETINE DELAYED RELEASE CAPSULES, USP safely and effectively. See full prescribing information for DULOXETINE DELAYED RELEASE CAPSULES, USP. DULOXETINE delayed-release capsules, for oral use. Initial U.S. Approval:2004
49252-008-182020-01-31C16284748780-19d75b9d0-43b4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DULOXETINE DELAYED RELEASE CAPSULES, USP safely and effectively. See full prescribing information for DULOXETINE DELAYED RELEASE CAPSULES, USP. DULOXETINE delayed-release capsules, for oral use. Initial U.S. Approval:2004
49252-008-572020-01-31C16284748780-19d75b9d0-43b4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DULOXETINE DELAYED RELEASE CAPSULES, USP safely and effectively. See full prescribing information for DULOXETINE DELAYED RELEASE CAPSULES, USP. DULOXETINE delayed-release capsules, for oral use. Initial U.S. Approval:2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49252-008-10duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE306
49252-008-11duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE606
49252-008-12duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE906
49252-008-18duloxetine1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10006
49252-008-57duloxetine100 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49252-008DULOXETINE CAPSULE, DELAYED RELEASE [INVENTIA HEALTHCARE PRIVATE LIMITED]3Current NDC, Legacy NDC, 5 package rows20221223_eab90059-ea1c-46c1-884d-c15e7c562a01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSNeab90059-ea1c-46c1-884d-c15e7c562a016
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNeab90059-ea1c-46c1-884d-c15e7c562a016
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNeab90059-ea1c-46c1-884d-c15e7c562a016
596926duloxetine 20 MG Delayed Release Oral CapsuleSCDeab90059-ea1c-46c1-884d-c15e7c562a016
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDeab90059-ea1c-46c1-884d-c15e7c562a016
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDeab90059-ea1c-46c1-884d-c15e7c562a016
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSYeab90059-ea1c-46c1-884d-c15e7c562a016
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYeab90059-ea1c-46c1-884d-c15e7c562a016
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYeab90059-ea1c-46c1-884d-c15e7c562a016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49252-008-104925200081030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-008-10) 2015-12-050000-00-00NoNoCurrent
49252-008-114925200081160 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-008-11) 2015-12-050000-00-00NoNoCurrent
49252-008-124925200081290 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-008-12) 2015-12-050000-00-00NoNoCurrent
49252-008-18492520008181000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-008-18) 2015-12-050000-00-00NoNoCurrent
49252-008-5749252000857100 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (49252-008-57) 2015-12-050000-00-00NoNoCurrent