FDA.reportPublic FDA data

DULOXETINE

Product NDC
63187-702
11-digit product format
631870702
Labeler code
63187
Product ID
63187-702_baacd94b-8cee-45ad-9bb4-cd12a8cfbd58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Proficient Rx LP
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-702-30DULOXETINEDELAYED-RELEASE30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS305
63187-702-60DULOXETINEDELAYED-RELEASE60 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS605
63187-702-90DULOXETINEDELAYED-RELEASE90 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-702-30EA - Each63187-702fb0885c5-b639-407f-8bba-4530a463b0a512016-09-02
63187-702-60EA - Each63187-7024045bd3f-2808-4159-a335-4f5c2d9c2b6512016-09-02
63187-702-90EA - Each63187-70205b220e0-f51d-4d4d-a05c-efb069dbd04112018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-702DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20240216_41c86c02-68c0-4db5-af1a-941b0d2ffe11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN41c86c02-68c0-4db5-af1a-941b0d2ffe115
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD41c86c02-68c0-4db5-af1a-941b0d2ffe115
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY41c86c02-68c0-4db5-af1a-941b0d2ffe115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-702-306318707023030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63187-702-30) 2016-05-020000-00-00NoNoCurrent
63187-702-606318707026060 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63187-702-60) 2016-05-020000-00-00NoNoCurrent
63187-702-906318707029090 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63187-702-90) 2016-05-020000-00-00NoNoCurrent