FDA.reportPublic FDA data

DULOXETINE

Product NDC
62034-021
11-digit product format
620340021
Labeler code
62034
Product ID
62034-021_34b202a4-17c8-5300-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA203088
Marketing category
ANDA
Marketing start
2016-04-01
Marketing end
0000-00-00
Substance
DULOXETINE HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
62034-021-772020-01-31C16284748780-19d75b9d1-1c92-f424-e053-dadaa90a57ceThese 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 USP for oral use. Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62034-021-11DULOXETINEDELAYED-RELEASE1 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE PELLETS14
62034-021-77DULOXETINEDELAYED-RELEASE100 in 1 BOX, UNIT-DOSECAPSULE, DELAYED RELEASE PELLETS1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62034-021DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BLENHEIM PHARMACAL, INC.]4Legacy NDC, 2 package rows20160607_c49f4fe2-1a2f-46fd-9dd1-45d54fdd1d75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNc49f4fe2-1a2f-46fd-9dd1-45d54fdd1d754
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNc49f4fe2-1a2f-46fd-9dd1-45d54fdd1d754
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDc49f4fe2-1a2f-46fd-9dd1-45d54fdd1d754
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDc49f4fe2-1a2f-46fd-9dd1-45d54fdd1d754
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYc49f4fe2-1a2f-46fd-9dd1-45d54fdd1d754
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYc49f4fe2-1a2f-46fd-9dd1-45d54fdd1d754

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
62034-021-11620340021111 in 1 BLISTER PACKHistorical
62034-021-7762034002177100 in 1 BOX, UNIT-DOSEHistorical