donepezil hydrochloride

Product NDC
43547-382
11-digit product format
435470382
Labeler code
43547
Product ID
43547-382_0de518b0-75a0-466f-9e20-15c2e00aefbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
donepezil hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA203713
Marketing category
ANDA
Marketing start
2016-12-05
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-382-03EA - Each43547-382a1c600f4-2ec8-479b-901c-2aa954d885e112017-03-06
43547-382-09EA - Each43547-3827cd1bcce-ad1c-40d8-941e-b0622bfcb9a412017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-382DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]2Legacy NDC20200305_64c81ee1-aee6-4f44-b048-c301d0304ff5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-382-034354703820330 TABLET, FILM COATED in 1 BOTTLE (43547-382-03) 2016-12-050000-00-00NoNoCurrent
43547-382-094354703820990 TABLET, FILM COATED in 1 BOTTLE (43547-382-09) 2016-12-050000-00-00NoNoCurrent
43547-382-1043547038210100 TABLET, FILM COATED in 1 BOTTLE (43547-382-10) 2016-12-050000-00-00NoNoCurrent
43547-382-5043547038250500 TABLET, FILM COATED in 1 BOTTLE (43547-382-50) 2016-12-050000-00-00NoNoCurrent