FDA.reportPublic FDA data

Donepezil Hydrochloride

Product NDC
71205-948
11-digit product format
712050948
Labeler code
71205
Product ID
71205-948_b974cd85-fbe8-40e4-89a7-b6c6845172e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203104
Marketing category
ANDA
Marketing start
2015-03-01
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
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7Product name120221214
d7e50b51-94ef-29ef-8273-837d555048c1Product name920160811

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-948-00Donepezil Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1002
71205-948-30Donepezil Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
71205-948-55Donepezil Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5002
71205-948-60Donepezil Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602
71205-948-90Donepezil Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-948-00EA - Each71205-948c07da109-4360-4e1e-be0e-1124f88fc0d012021-06-02
71205-948-30EA - Each71205-9482821902e-f47b-44a8-aad4-3a3a81c15cc512021-09-07
71205-948-55EA - Each71205-948cbebab1f-db37-4fd5-ab59-82b81433027d12021-06-02
71205-948-60EA - Each71205-9486099b8d3-8feb-492a-b6e8-04e9cbfd3bf912021-06-02
71205-948-90EA - Each71205-9482189a8d3-465e-4670-a835-6a7eba81316d12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-948DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 5 package rows20220426_32709bda-53d0-4d57-9f0b-3e1f28e39f25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100184donepezil HCl 23 MG Oral TabletPSN32709bda-53d0-4d57-9f0b-3e1f28e39f252
1100184donepezil hydrochloride 23 MG Oral TabletSCD32709bda-53d0-4d57-9f0b-3e1f28e39f252

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-948-0071205094800100 TABLET, FILM COATED in 1 BOTTLE (71205-948-00) 2020-11-190000-00-00NoNoCurrent
71205-948-307120509483030 TABLET, FILM COATED in 1 BOTTLE (71205-948-30) 2020-11-190000-00-00NoNoCurrent
71205-948-5571205094855500 TABLET, FILM COATED in 1 BOTTLE (71205-948-55) 2020-11-190000-00-00NoNoCurrent
71205-948-607120509486060 TABLET, FILM COATED in 1 BOTTLE (71205-948-60) 2020-11-190000-00-00NoNoCurrent
71205-948-907120509489090 TABLET, FILM COATED in 1 BOTTLE (71205-948-90) 2020-11-190000-00-00NoNoCurrent