Adlarity

Product NDC
65038-055
11-digit product format
650380055
Labeler code
65038
Product ID
65038-055_9697bb6c-5a73-4bb9-8792-271fdf733c5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Corium, Inc.
Application
NDA212304
Marketing category
NDA
Marketing start
2022-03-11
Marketing end
0000-00-00
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
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
65038-055-01EA - Each65038-055a9d5fc2b-2035-42aa-af7a-7046ad13012812022-07-06
65038-055-03EA - Each65038-055c73528ea-0965-4c80-9943-bd666abf123712022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65038-055ADLARITY (DONEPEZIL HYDROCHLORIDE) PATCH [CORIUM, LLC.]3Legacy NDC20230219_1cb44c65-00e8-4b5c-99c2-ad15173115a0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65038-055-01650380055011 PATCH in 1 POUCH (65038-055-01) 1 patch2022-09-070000-00-00NoNoCurrent
65038-055-03650380055034 POUCH in 1 CARTON (65038-055-03) > 1 PATCH in 1 POUCH (65038-055-01) 4 pouch2022-03-110000-00-00NoNoCurrent
65038-055-076503800550710 CARTON in 1 CARTON (65038-055-07) > 1 POUCH in 1 CARTON (65038-055-04) > 1 PATCH in 1 POUCH (65038-055-10) 10 carton2022-03-110000-00-00YesNoCurrent
65038-055-10650380055101 PATCH in 1 POUCH (65038-055-10) 1 patch2022-09-070000-00-00NoNoCurrent