Donepezil Hydrochloride

Product NDC
43063-659
11-digit product format
430630659
Labeler code
43063
Product ID
43063-659_efe3f984-3fc7-0bfe-e053-2995a90a98aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA201146
Marketing category
ANDA
Marketing start
2012-08-17
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-659-90EA - Each43063-65935cad6ca-4a2b-46dc-ac03-f03d2913c5f812016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-659DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]22Legacy NDC20241016_2be9f49d-e7db-4846-e054-00144ff8d46c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-659-904306306599090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-659-90) 2016-03-040000-00-00NoNoCurrent