FDA.reportPublic FDA data

Duloxetine

Product NDC
50090-3205
11-digit product format
500903205
Labeler code
50090
Product ID
50090-3205_bb6e2af6-0020-470b-addb-df7bb4724ac7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203088
Marketing category
ANDA
Marketing start
2014-06-11
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
Brand name suffix
Delayed-Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULOXETINE HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596930

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
50090-3205-02023-02-07C16284748780-1f386c649-e24b-0266-e053-dadaa90a7c1aThese 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
50090-3205-12023-02-07C16284748780-1f386c649-e24b-0266-e053-dadaa90a7c1aThese 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
50090-3205-0Duloxetine Delayed-Release30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS3015
50090-3205-1Duloxetine Delayed-Release90 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS9015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3205-0EA - Each50090-3205be0c3cf7-0674-4070-aaea-9668b320d46e12018-12-13
50090-3205-1EA - Each50090-3205bd9c0251-619f-4408-91a3-169a47277d8412018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3205DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [A-S MEDICATION SOLUTIONS]15Current NDC, Legacy NDC, 2 package rows20240612_3eb24fa9-921b-4bdb-9e0a-c82cb600df0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN3eb24fa9-921b-4bdb-9e0a-c82cb600df0f15
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD3eb24fa9-921b-4bdb-9e0a-c82cb600df0f15
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY3eb24fa9-921b-4bdb-9e0a-c82cb600df0f15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3205-05009032050030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (50090-3205-0) 2017-12-050000-00-00NoNoCurrent
50090-3205-15009032050190 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (50090-3205-1) 2017-10-240000-00-00NoNoCurrent