FDA.reportPublic FDA data

donepezil hydrochloride

Product NDC
29300-250
11-digit product format
293000250
Labeler code
29300
Product ID
29300-250_88d3f867-45f4-42fb-93f8-235c2f594760
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
donepezil hydrochloride
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA204831
Marketing category
ANDA
Marketing start
2016-11-10
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
donepezil hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DONEPEZIL HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3O2T2PJ89D
Rxcui997220, 997223, 997226, 997229

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94db636e-a074-45fd-8e8d-331920a99436Product name420250103
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7Product name120221214
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d7e50b51-94ef-29ef-8273-837d555048c1Product name920160811
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29300-250-11donepezil hydrochloride10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1012
29300-250-87donepezil hydrochloride3 in 1 CARTONTABLET, ORALLY DISINTEGRATING312

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-250-11EA - Each29300-250a5b900d5-3bcd-47c6-93fd-54d3a88e68bd12018-05-09
29300-250-87EA - Each29300-2506571e11c-aec5-40ee-85fb-4619c012d93c12018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-250DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [UNICHEM PHARMACEUTICALS (USA), INC.]11Current NDC, Legacy NDC, 2 package rows20201204_1a8906ce-96dc-4bc8-81c1-5db67a187aac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997220donepezil HCl 10 MG Disintegrating Oral TabletPSN1a8906ce-96dc-4bc8-81c1-5db67a187aac12
997223donepezil HCl 10 MG Oral TabletPSN1a8906ce-96dc-4bc8-81c1-5db67a187aac12
997226donepezil HCl 5 MG Disintegrating Oral TabletPSN1a8906ce-96dc-4bc8-81c1-5db67a187aac12
997229donepezil HCl 5 MG Oral TabletPSN1a8906ce-96dc-4bc8-81c1-5db67a187aac12
997220donepezil hydrochloride 10 MG Disintegrating Oral TabletSCD1a8906ce-96dc-4bc8-81c1-5db67a187aac12
997223donepezil hydrochloride 10 MG Oral TabletSCD1a8906ce-96dc-4bc8-81c1-5db67a187aac12
997226donepezil hydrochloride 5 MG Disintegrating Oral TabletSCD1a8906ce-96dc-4bc8-81c1-5db67a187aac12
997229donepezil hydrochloride 5 MG Oral TabletSCD1a8906ce-96dc-4bc8-81c1-5db67a187aac12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-250-112930002501110 in 1 BLISTER PACKHistorical
29300-250-87293000250873 BLISTER PACK in 1 CARTON (29300-250-87) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (29300-250-11) 3 blister pack2018-02-280000-00-00NoNoCurrent