Label: DONEPEZIL HYDROCHLORIDE tablet, film coated
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NDC Code(s):
70771-1320-0,
70771-1320-1,
70771-1320-2,
70771-1320-3, view more70771-1320-4, 70771-1320-5, 70771-1320-9
- 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
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1320 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P) DONEPEZIL HYDROCHLORIDE 23 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Product Characteristics Color RED (red-brown) Score no score Shape ROUND (round) Size 8mm Flavor Imprint Code 521 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1320-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/07/2018 2 NDC:70771-1320-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/07/2018 3 NDC:70771-1320-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/07/2018 4 NDC:70771-1320-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/07/2018 5 NDC:70771-1320-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/07/2018 6 NDC:70771-1320-4 10 in 1 CARTON 03/07/2018 6 NDC:70771-1320-2 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 ANDA203162 03/07/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1320) , MANUFACTURE(70771-1320)
