FDA.reportPublic FDA data

Duloxetine

Product NDC
51655-237
11-digit product format
516550237
Labeler code
51655
Product ID
51655-237_4af5ec77-5715-4abd-e063-6294a90ab43e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA208706
Marketing category
ANDA
Marketing start
2021-04-23
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Duloxetine
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-237-252023-03-27C16284748780-1f386c64a-1e47-0266-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
51655-237-252023-01-30C16284748780-1f386c64a-1e47-0266-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
51655-237-25Duloxetine60 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-237DULOXETINE CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 1 package rows20241218_c194a7b0-1e7e-a32b-e053-2995a90a7dbd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNc194a7b0-1e7e-a32b-e053-2995a90a7dbd4
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDc194a7b0-1e7e-a32b-e053-2995a90a7dbd4
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYc194a7b0-1e7e-a32b-e053-2995a90a7dbd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-237-255165502372560 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51655-237-25) 2021-04-230000-00-00NoNoCurrent