Donepezil Hydrochloride

Product NDC
0378-1025
11-digit product format
003781025
Labeler code
0378
Product ID
0378-1025_ef1015bb-2d5c-4a14-bf0c-8225b87ca1c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
donepezil hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA202656
Marketing category
ANDA
Marketing start
2015-12-11
Marketing end
0000-00-00
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
23 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1025-77EA - Each0378-10250e5f721f-fa08-4b07-a653-a3dbe0e9533112016-01-13
0378-1025-93EA - Each0378-10257f92f9eb-4251-4134-b7fa-9a5a135b35fd12016-01-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-1025-770037810257790 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1025-77) 2015-12-110000-00-00NoNoCurrent
0378-1025-930037810259330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1025-93) 2015-12-110000-00-00NoNoCurrent