Label: DONEPEZIL HYDROCHLORIDE tablet, orally disintegrating
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NDC Code(s):
65841-721-01,
65841-721-05,
65841-721-06,
65841-721-10, view more65841-721-16, 65841-721-30, 65841-722-01, 65841-722-05, 65841-722-06, 65841-722-10, 65841-722-16, 65841-722-30
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 13, 2022
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- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride tablet, orally disintegratingProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-721 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P) DONEPEZIL HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (UNII: 2S7830E561) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) PEPPERMINT (UNII: V95R5KMY2B) STRAWBERRY (UNII: 4J2TY8Y81V) SUCRALOSE (UNII: 96K6UQ3ZD4) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 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 Marketing Start Date Marketing End Date 1 NDC:65841-721-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/11/2011 2 NDC:65841-721-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/11/2011 3 NDC:65841-721-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/11/2011 4 NDC:65841-721-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/11/2011 5 NDC:65841-721-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 05/11/2011 6 NDC:65841-721-30 10 in 1 CARTON 05/11/2011 6 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 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 disintegratingProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-722 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P) DONEPEZIL HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (UNII: 2S7830E561) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) PEPPERMINT (UNII: V95R5KMY2B) STRAWBERRY (UNII: 4J2TY8Y81V) SUCRALOSE (UNII: 96K6UQ3ZD4) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 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 Marketing Start Date Marketing End Date 1 NDC:65841-722-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/11/2011 2 NDC:65841-722-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/11/2011 3 NDC:65841-722-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/11/2011 4 NDC:65841-722-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/11/2011 5 NDC:65841-722-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 05/11/2011 6 NDC:65841-722-30 10 in 1 CARTON 05/11/2011 6 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090175 05/11/2011 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-721, 65841-722) , MANUFACTURE(65841-721, 65841-722)