Cymbalta

Product NDC
55289-028
11-digit product format
552890028
Labeler code
55289
Product ID
55289-028_d83eeef7-d8f1-6627-e053-2995a90a850c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine hydrochloride
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
NDA021427
Marketing category
NDA
Marketing start
2010-01-15
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-028-21EA - Each55289-028f513c2fb-e30e-4b23-8130-c1f01d84765e12012-07-24
55289-028-30EA - Each55289-0281b709b6a-725c-4124-9101-c3174007800812012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55289-028-215528900282121 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-028-21) 2016-07-120000-00-00NoNoCurrent
55289-028-305528900283030 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-028-30) 2016-07-120000-00-00NoNoCurrent