Home NDC 24979-004 Donepezil Hydrochloride
Product NDC 24979-004
11-digit product format 249790004
Labeler code 24979
Product ID 24979-004_e1f7708c-55a7-4201-86c6-089ff0cce422
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Donepezil Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DONEPEZIL HYDROCHLORIDE 23 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 3O2T2PJ89D
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 24979-004-03 2023-02-01 C162847 48780-1 f386c649-dd14-0266-e053-dadaa90a7c1a Donepezil Hydrochloride Tablets These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABELTS safely and effectively. see full prescribing information for DONEPEZIL HYDROCHLORIDE TABELTS. Donepezil Hydrochloride (donepezil hydrochloride) TABLET, for ORAL use. Initial U.S. Approval: 1996 24979-004-03 2023-02-01 C162847 48780-1 f386c649-dd14-0266-e053-dadaa90a7c1a Donepezil Hydrochloride Tablets These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABELTS safely and effectively. see full prescribing information for DONEPEZIL HYDROCHLORIDE TABELTS. Donepezil Hydrochloride (donepezil hydrochloride) TABLET, for ORAL use. Initial U.S. Approval: 1996 24979-004-06 2023-02-01 C162847 48780-1 f386c649-dd14-0266-e053-dadaa90a7c1a Donepezil Hydrochloride Tablets These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABELTS safely and effectively. see full prescribing information for DONEPEZIL HYDROCHLORIDE TABELTS. Donepezil Hydrochloride (donepezil hydrochloride) TABLET, for ORAL use. Initial U.S. Approval: 1996 24979-004-06 2023-02-01 C162847 48780-1 f386c649-dd14-0266-e053-dadaa90a7c1a Donepezil Hydrochloride Tablets These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABELTS safely and effectively. see full prescribing information for DONEPEZIL HYDROCHLORIDE TABELTS. Donepezil Hydrochloride (donepezil hydrochloride) TABLET, for ORAL use. Initial U.S. Approval: 1996 24979-004-07 2023-02-01 C162847 48780-1 f386c649-dd14-0266-e053-dadaa90a7c1a Donepezil Hydrochloride Tablets These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABELTS safely and effectively. see full prescribing information for DONEPEZIL HYDROCHLORIDE TABELTS. Donepezil Hydrochloride (donepezil hydrochloride) TABLET, for ORAL use. Initial U.S. Approval: 1996 24979-004-07 2023-02-01 C162847 48780-1 f386c649-dd14-0266-e053-dadaa90a7c1a Donepezil Hydrochloride Tablets These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABELTS safely and effectively. see full prescribing information for DONEPEZIL HYDROCHLORIDE TABELTS. Donepezil Hydrochloride (donepezil hydrochloride) TABLET, for ORAL use. Initial U.S. Approval: 1996 24979-004-03 2023-01-30 C162847 48780-1 f386c649-dd14-0266-e053-dadaa90a7c1a Donepezil Hydrochloride Tablets These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABELTS safely and effectively. see full prescribing information for DONEPEZIL HYDROCHLORIDE TABELTS. Donepezil Hydrochloride (donepezil hydrochloride) TABLET, for ORAL use. Initial U.S. Approval: 1996 24979-004-03 2023-01-30 C162847 48780-1 f386c649-dd14-0266-e053-dadaa90a7c1a Donepezil Hydrochloride Tablets These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABELTS safely and effectively. see full prescribing information for DONEPEZIL HYDROCHLORIDE TABELTS. Donepezil Hydrochloride (donepezil hydrochloride) TABLET, for ORAL use. Initial U.S. Approval: 1996 24979-004-06 2023-01-30 C162847 48780-1 f386c649-dd14-0266-e053-dadaa90a7c1a Donepezil Hydrochloride Tablets These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABELTS safely and effectively. see full prescribing information for DONEPEZIL HYDROCHLORIDE TABELTS. Donepezil Hydrochloride (donepezil hydrochloride) TABLET, for ORAL use. Initial U.S. Approval: 1996 24979-004-06 2023-01-30 C162847 48780-1 f386c649-dd14-0266-e053-dadaa90a7c1a Donepezil Hydrochloride Tablets These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABELTS safely and effectively. see full prescribing information for DONEPEZIL HYDROCHLORIDE TABELTS. Donepezil Hydrochloride (donepezil hydrochloride) TABLET, for ORAL use. Initial U.S. Approval: 1996 24979-004-07 2023-01-30 C162847 48780-1 f386c649-dd14-0266-e053-dadaa90a7c1a Donepezil Hydrochloride Tablets These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABELTS safely and effectively. see full prescribing information for DONEPEZIL HYDROCHLORIDE TABELTS. Donepezil Hydrochloride (donepezil hydrochloride) TABLET, for ORAL use. Initial U.S. Approval: 1996 24979-004-07 2023-01-30 C162847 48780-1 f386c649-dd14-0266-e053-dadaa90a7c1a Donepezil Hydrochloride Tablets These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABELTS safely and effectively. see full prescribing information for DONEPEZIL HYDROCHLORIDE TABELTS. Donepezil Hydrochloride (donepezil hydrochloride) TABLET, for ORAL use. Initial U.S. Approval: 1996
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 24979-004-03 Donepezil Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 22 24979-004-06 Donepezil Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 22 24979-004-07 Donepezil Hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 22
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DONEPEZIL HYDROCHLORIDE ACTIVE INGREDIENT 3O2T2PJ89D DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 DONEPEZIL ACTIVE MOIETY 8SSC91326P DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 CANDELILLA WAX INACTIVE INGREDIENT WL0328HX19 DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 HYPROMELLOSE 2208 (4000 MPA.S) INACTIVE INGREDIENT 39J80LT57T DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A INACTIVE INGREDIENT NX76LV5T8J DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 TALC INACTIVE INGREDIENT 7SEV7J4R1U DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24979-004 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, LLC] 22 Current NDC, Legacy NDC, 3 package rows 20250410_12a755c5-1ad9-43d1-832a-eb2ff17bd693.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 24979-004-03 24979000403 1000 in 1 BOTTLE Historical 24979-004-06 24979000406 30 TABLET, FILM COATED in 1 BOTTLE (24979-004-06) 2015-03-01 0000-00-00 No No Current 24979-004-07 24979000407 90 TABLET, FILM COATED in 1 BOTTLE (24979-004-07) 2015-09-22 0000-00-00 No No Current