FDA.reportPublic FDA data

DONEPEZIL HYDROCHLORIDE

Product NDC
68180-527
11-digit product format
681800527
Labeler code
68180
Product ID
68180-527_f8867ea9-a608-4b0f-9052-fa5c44d7e7c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DONEPEZIL HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA202782
Marketing category
ANDA
Marketing start
2015-12-21
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
23 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 HYDROCHLORIDE23 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3O2T2PJ89D
Rxcui1100184

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94db636e-a074-45fd-8e8d-331920a99436Product name420250103
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7Product name120221214
d7e50b51-94ef-29ef-8273-837d555048c1Product name920160811

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-527-06DONEPEZIL HYDROCHLORIDE30 in 1 BOTTLETABLET307
68180-527-09DONEPEZIL HYDROCHLORIDE90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-527-06EA - Each68180-52701f61b71-ecd2-4260-90a1-a929ce5af83012016-02-04
68180-527-09EA - Each68180-52765a27936-3779-4526-abe9-9bd9b95ad55312016-02-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-527DONEPEZIL HYDROCHLORIDE TABLET [LUPIN PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 2 package rows20241206_03e26183-3e07-45e8-a414-a8bad32483e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100184donepezil HCl 23 MG Oral TabletPSN03e26183-3e07-45e8-a414-a8bad32483e27
1100184donepezil hydrochloride 23 MG Oral TabletSCD03e26183-3e07-45e8-a414-a8bad32483e27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-527-066818005270630 TABLET in 1 BOTTLE (68180-527-06) 30 tablet2015-12-210000-00-00NoNoCurrent
68180-527-096818005270990 TABLET in 1 BOTTLE (68180-527-09) 90 tablet2015-12-210000-00-00NoNoCurrent