donepezil hydrochloride

Product NDC
68382-347
11-digit product format
683820347
Labeler code
68382
Product ID
68382-347_8c8f4e5f-acf1-443f-a890-6665c7cc9aa4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
donepezil hydrochloride
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA090175
Marketing category
ANDA
Marketing start
2011-05-11
Marketing end
0000-00-00
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
10 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
68382-347-06EA - Each68382-34714750f22-2ce8-424a-85e6-b966a62b0c8b12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-347-0168382034701100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-347-01) 2011-05-110000-00-00NoNoCurrent
68382-347-0568382034705500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-347-05) 2011-05-110000-00-00NoNoCurrent
68382-347-066838203470630 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-347-06) 2011-05-110000-00-00NoNoCurrent
68382-347-10683820347101000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-347-10) 2011-05-110000-00-00NoNoCurrent
68382-347-166838203471690 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-347-16) 2011-05-110000-00-00NoNoCurrent
68382-347-7768382034777100 BLISTER PACK in 1 CARTON (68382-347-77) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-347-30) 100 blister pack2011-05-110000-00-00NoNoCurrent