Duloxetine

Product NDC
55700-727
11-digit product format
557000727
Labeler code
55700
Product ID
55700-727_bb8fec7f-1868-42d9-8cfb-a180fe1124e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA208706
Marketing category
ANDA
Marketing start
2019-02-22
Marketing end
2026-05-31
Substance
DULOXETINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag
No
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55700-727-30Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE307
55700-727-60Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-727DULOXETINE CAPSULE, DELAYED RELEASE [QUALITY CARE PRODUCTS, LLC]7Current NDC, Legacy NDC, 2 package rows20241220_4d489d05-e767-498f-8827-c03ebfc512e0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-727-305570007273030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-727-30) 2019-02-222026-05-31NoNoCurrent
55700-727-605570007276060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-727-60) 2019-02-220000-00-00NoNoCurrent