FDA.reportPublic FDA data

Donepezil Hydrochloride

Product NDC
42582-312
11-digit product format
425820312
Labeler code
42582
Product ID
42582-312_dc6e4127-412d-40b6-b313-46d489e7e181
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bi-Coastal Pharma International LLC
Application
ANDA090551
Marketing category
ANDA
Marketing start
2015-07-01
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94db636e-a074-45fd-8e8d-331920a99436Product name420250103
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7Product name120221214
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d7e50b51-94ef-29ef-8273-837d555048c1Product name920160811
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42582-312-092023-01-30C16284748780-1f386c649-aa90-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996
42582-312-182023-01-30C16284748780-1f386c649-aa90-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996
42582-312-302023-01-30C16284748780-1f386c649-aa90-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42582-312-09Donepezil Hydrochloride10mg90 in 1 BOTTLETABLET, FILM COATED903
42582-312-18Donepezil Hydrochloride10mg500 in 1 BOTTLETABLET, FILM COATED5003
42582-312-30Donepezil Hydrochloride10mg30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42582-312-09EA - Each42582-31235772754-552f-4413-ab9c-dda9b805699812018-03-08
42582-312-30EA - Each42582-3123d8ecb72-78e0-498c-8625-ee10c4771ef312018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42582-312DONEPEZIL HYROCHLORIDE 5MG (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED DONEPEZIL HYDROCHLORIDE 10MG (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [BI‐COASTAL PHARMA INTERNATIONAL LLC]3Legacy NDC, 3 package rows20190109_6ba90d01-3a96-4780-99df-2b4af8c3ea38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN6ba90d01-3a96-4780-99df-2b4af8c3ea383
997229donepezil HCl 5 MG Oral TabletPSN6ba90d01-3a96-4780-99df-2b4af8c3ea383
997223donepezil hydrochloride 10 MG Oral TabletSCD6ba90d01-3a96-4780-99df-2b4af8c3ea383
997229donepezil hydrochloride 5 MG Oral TabletSCD6ba90d01-3a96-4780-99df-2b4af8c3ea383

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42582-312-094258203120990 TABLET, FILM COATED in 1 BOTTLE (42582-312-09) 2016-10-050000-00-00NoNoCurrent
42582-312-1842582031218500 TABLET, FILM COATED in 1 BOTTLE (42582-312-18) 2016-10-050000-00-00NoNoCurrent
42582-312-304258203123030 TABLET, FILM COATED in 1 BOTTLE (42582-312-30) 2016-10-050000-00-00NoNoCurrent