Donepezil

Product NDC: 68071-3198
11-digit product format: 680713198
Labeler code: 68071
Product ID: 68071-3198_d5930cc8-00ba-de99-e053-2a95a90ae51b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Donepezil hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA203034
Marketing category: ANDA
Marketing start: 2015-02-02
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-3198-9	2020-10-12	C162847	48780-1	9d75b9d0-6007-f424-e053-dadaa90a57ce	51c9bd8b-d603-54a0-e054-00144ff8d46c
68071-3198-9	2020-01-31	C162847	48780-1	9d75b9d0-6007-f424-e053-dadaa90a57ce	51c9bd8b-d603-54a0-e054-00144ff8d46c

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3O2T2PJ89D	DONEPEZIL HYDROCHLORIDE	120011-70-3	DONEPEZIL HYDROCHLORIDE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-3198-9	68071319809	90 TABLET in 1 BOTTLE (68071-3198-9)	90 tablet	2017-06-12	0000-00-00	No	No	Current