FDA.reportPublic FDA data

DULOXETINE

Product NDC
63187-735
11-digit product format
631870735
Labeler code
63187
Product ID
63187-735_c40e425f-a9b7-4ab5-93ea-6e14ae0b77f9
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
60 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 HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596934

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
63187-735-30DULOXETINEDELAYED-RELEASE30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS304
63187-735-60DULOXETINEDELAYED-RELEASE60 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS604
63187-735-90DULOXETINEDELAYED-RELEASE90 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-735-30EA - Each63187-7351f59a6b9-fe2b-4e42-8998-4d35b061821b12018-06-11
63187-735-60EA - Each63187-735fae36508-23a4-4ddc-b68d-16c665a79b3512018-03-08
63187-735-90EA - Each63187-73530af64b1-ce6f-4428-9401-9de7f3ae1ee412018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-735DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20221027_22a8cc15-17fb-4c4e-8d2a-de5755ed6031.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN22a8cc15-17fb-4c4e-8d2a-de5755ed60314
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD22a8cc15-17fb-4c4e-8d2a-de5755ed60314
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY22a8cc15-17fb-4c4e-8d2a-de5755ed60314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-735-306318707353030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63187-735-30) 2016-07-010000-00-00NoNoCurrent
63187-735-606318707356060 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63187-735-60) 2016-07-010000-00-00NoNoCurrent
63187-735-906318707359090 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63187-735-90) 2016-07-010000-00-00NoNoCurrent