Duloxetine

Product NDC
55700-605
11-digit product format
557000605
Labeler code
55700
Product ID
55700-605_179d513e-6318-474c-8d28-fbc90f9c481e
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
2018-04-20
Marketing end
2026-05-31
Substance
DULOXETINE HYDROCHLORIDE
Active strength
30 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
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55700-605-30Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE307
55700-605-60Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-605-30EA - Each55700-60541232682-ace9-4150-aa0d-d732db32f90c12018-05-09
55700-605-60EA - Each55700-6057000015e-82d1-40ea-ab08-4f853694bdf312018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-605DULOXETINE CAPSULE, DELAYED RELEASE [QUALITY CARE PRODUCTS LLC]7Current NDC, Legacy NDC, 2 package rows20241219_d20b6f37-25d6-4eaa-96ba-da6a73300687.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-605-305570006053030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-605-30) 2018-04-202026-05-31NoNoCurrent
55700-605-605570006056060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-605-60) 2018-04-202026-05-31NoNoCurrent