donepezil hydrochloride

Generic: donepezil hydrochloride

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name donepezil hydrochloride
Generic Name donepezil hydrochloride
Labeler macleods pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

donepezil hydrochloride 5 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-027
Product ID 33342-027_4bf742a3-3c8f-4bd3-b973-54370cbef345
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201146
Listing Expiration 2026-12-31
Marketing Start 2012-08-17

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342027
Hyphenated Format 33342-027

Supplemental Identifiers

RxCUI
997220 997223 997226 997229 1100184
UPC
0333342061102 0333342061072 0333342030078 0333342027108 0333342027078 0333342029072 0333342029607 0333342027153 0333342028150 0333342030603
UNII
3O2T2PJ89D

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name donepezil hydrochloride (source: ndc)
Generic Name donepezil hydrochloride (source: ndc)
Application Number ANDA201146 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (33342-027-07)
  • 90 TABLET, FILM COATED in 1 BOTTLE (33342-027-10)
  • 10 BLISTER PACK in 1 CARTON (33342-027-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 500 TABLET, FILM COATED in 1 BOTTLE (33342-027-15)
  • 5 BLISTER PACK in 1 CARTON (33342-027-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 1000 TABLET, FILM COATED in 1 BOTTLE (33342-027-44)
source: ndc

Packages (6)

33342-027-07 30 TABLET, FILM COATED in 1 BOTTLE (33342-027-07) 33342-027-10 90 TABLET, FILM COATED in 1 BOTTLE (33342-027-10) 33342-027-12 10 BLISTER PACK in 1 CARTON (33342-027-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK 33342-027-15 500 TABLET, FILM COATED in 1 BOTTLE (33342-027-15) 33342-027-31 5 BLISTER PACK in 1 CARTON (33342-027-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK 33342-027-44 1000 TABLET, FILM COATED in 1 BOTTLE (33342-027-44)

Ingredients (1)

donepezil hydrochloride (5 mg/1)

Linked Drug Pages (1)

Donepezil Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4bf742a3-3c8f-4bd3-b973-54370cbef345", "openfda": {"upc": ["0333342061102", "0333342061072", "0333342030078", "0333342027108", "0333342027078", "0333342029072", "0333342029607", "0333342027153", "0333342028150", "0333342030603"], "unii": ["3O2T2PJ89D"], "rxcui": ["997220", "997223", "997226", "997229", "1100184"], "spl_set_id": ["06dd25a5-1bf2-446d-ad75-ff9d55117660"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (33342-027-07)", "package_ndc": "33342-027-07", "marketing_start_date": "20120817"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (33342-027-10)", "package_ndc": "33342-027-10", "marketing_start_date": "20120817"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-027-12)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "33342-027-12", "marketing_start_date": "20120817"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (33342-027-15)", "package_ndc": "33342-027-15", "marketing_start_date": "20141106"}, {"sample": false, "description": "5 BLISTER PACK in 1 CARTON (33342-027-31)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "33342-027-31", "marketing_start_date": "20120817"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (33342-027-44)", "package_ndc": "33342-027-44", "marketing_start_date": "20141106"}], "brand_name": "Donepezil Hydrochloride", "product_id": "33342-027_4bf742a3-3c8f-4bd3-b973-54370cbef345", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "33342-027", "generic_name": "Donepezil Hydrochloride", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Donepezil Hydrochloride", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA201146", "marketing_category": "ANDA", "marketing_start_date": "20120817", "listing_expiration_date": "20261231"}