FDA.reportPublic FDA data

DULOXETINE HYDROCHLORIDE

Product NDC
50771-203
11-digit product format
507710203
Labeler code
50771
Product ID
50771-203_4502c810-4eb5-29c4-e063-6394a90aefe4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Yaopharma Co., Ltd.
Application
ANDA207219
Marketing category
ANDA
Marketing start
2024-01-01
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 HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULOXETINE HYDROCHLORIDE60 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
50771-203-012024-06-24C16284748780-11030e365-6307-111a-e063-dadaa90a10e2DULOXETINE DELAYED-RELEASE CAPSULES, USP Rx only
50771-203-022024-06-24C16284748780-11030e365-6307-111a-e063-dadaa90a10e2DULOXETINE DELAYED-RELEASE CAPSULES, USP Rx only
50771-203-012024-01-30C16284748780-11030e365-6307-111a-e063-dadaa90a10e2DULOXETINE DELAYED-RELEASE CAPSULES, USP Rx only
50771-203-022024-01-30C16284748780-11030e365-6307-111a-e063-dadaa90a10e2DULOXETINE DELAYED-RELEASE CAPSULES, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50771-203-01DULOXETINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE PELLETS3011
50771-203-02DULOXETINE HYDROCHLORIDE500 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE PELLETS50011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50771-203DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [YAOPHARMA CO., LTD.]9Current NDC, Legacy NDC, 2 package rows20241220_90224073-178d-7ec5-e053-2995a90a20fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSN90224073-178d-7ec5-e053-2995a90a20fc11
596930DULoxetine 30 MG Delayed Release Oral CapsulePSN90224073-178d-7ec5-e053-2995a90a20fc11
596934DULoxetine 60 MG Delayed Release Oral CapsulePSN90224073-178d-7ec5-e053-2995a90a20fc11
596926duloxetine 20 MG Delayed Release Oral CapsuleSCD90224073-178d-7ec5-e053-2995a90a20fc11
596930duloxetine 30 MG Delayed Release Oral CapsuleSCD90224073-178d-7ec5-e053-2995a90a20fc11
596934duloxetine 60 MG Delayed Release Oral CapsuleSCD90224073-178d-7ec5-e053-2995a90a20fc11
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSY90224073-178d-7ec5-e053-2995a90a20fc11
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSY90224073-178d-7ec5-e053-2995a90a20fc11
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSY90224073-178d-7ec5-e053-2995a90a20fc11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50771-203-015077102030130 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (50771-203-01) 2024-01-010000-00-00NoNoCurrent
50771-203-0250771020302500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (50771-203-02) 2024-01-010000-00-00NoNoCurrent