Donepezil Hydrochloride

Product NDC
71335-0582
11-digit product format
713350582
Labeler code
71335
Product ID
71335-0582_d911da38-b70e-4ced-921f-540329b853d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090686
Marketing category
ANDA
Marketing start
2011-05-31
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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94db636e-a074-45fd-8e8d-331920a99436Product name420250103
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7Product name120221214
d7e50b51-94ef-29ef-8273-837d555048c1Product name920160811

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0582-1EA - Each71335-05829491c380-d5a7-4a07-b53b-4374ca7e7be212018-03-08
71335-0582-2EA - Each71335-05828db3276c-6eb7-4fc5-8ae0-6dd4ac123cd712018-03-08
71335-0582-3EA - Each71335-05824791c2a0-4923-406a-9b99-48d03117455512018-03-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0582-17133505820130 TABLET, FILM COATED in 1 BOTTLE (71335-0582-1) 2017-06-070000-00-00NoNoCurrent
71335-0582-27133505820260 TABLET, FILM COATED in 1 BOTTLE (71335-0582-2) 2017-06-070000-00-00NoNoCurrent
71335-0582-37133505820390 TABLET, FILM COATED in 1 BOTTLE (71335-0582-3) 2017-06-070000-00-00NoNoCurrent