Donepezil Hydrochloride

DONEPEZIL HYDROCHLORIDE- donepezil hydrochloride tablet, orally disintegrating
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-721-06 in bottle of 30 tablets

Donepezil Hydrochloride Orally Disintegrating Tablets USP, 5 mg

Rx only

30 tablets

Donepezil Hydrochloride Orally Disintegrating Tablets, 5 mg
(click image for full-size original)

NDC 65841-722-06 in bottle of 30 tablets

Donepezil Hydrochloride Orally Disintegrating Tablets USP, 10 mg

Rx only

30 tablets

Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg
(click image for full-size original)
DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-721
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DONEPEZIL HYDROCHLORIDE (DONEPEZIL) DONEPEZIL HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE, UNSPECIFIED
MAGNESIUM STEARATE
MANNITOL
PEPPERMINT
STRAWBERRY
SUCRALOSE
SILICON DIOXIDE
Product Characteristics
Color WHITE (WHITE TO OFF WHITE) Score no score
Shape ROUND (ROUND) Size 7mm
Flavor PEPPERMINT (flavor firmenich powder peppermint) , STRAWBERRY (flavor strawberry) Imprint Code ZF;14
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-721-06 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
2 NDC:65841-721-16 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
3 NDC:65841-721-01 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
4 NDC:65841-721-05 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
5 NDC:65841-721-10 1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
6 NDC:65841-721-30 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (65841-721-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090175 05/11/2011
DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-722
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DONEPEZIL HYDROCHLORIDE (DONEPEZIL) DONEPEZIL HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE, UNSPECIFIED
MAGNESIUM STEARATE
MANNITOL
PEPPERMINT
STRAWBERRY
SUCRALOSE
SILICON DIOXIDE
Product Characteristics
Color WHITE (WHITE TO OFF WHITE) Score no score
Shape ROUND (ROUND) Size 10mm
Flavor PEPPERMINT (flavor firmenich powder peppermint) , STRAWBERRY (flavor strawberry) Imprint Code ZF;15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-722-06 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
2 NDC:65841-722-16 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
3 NDC:65841-722-01 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
4 NDC:65841-722-05 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
5 NDC:65841-722-10 1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
6 NDC:65841-722-30 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (65841-722-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090175 05/11/2011
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (65841-721), ANALYSIS (65841-722), MANUFACTURE (65841-721), MANUFACTURE (65841-722)

Revised: 08/2020 Cadila Healthcare Limited

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