NDC Code(s) : 24979-004-06, 24979-004-03, 24979-004-07
Packager : TWi Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Donepezil HydrochlorideDonepezil Hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24979-004
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DONEPEZIL HYDROCHLORIDE(UNII: 3O2T2PJ89D)
(DONEPEZIL - UNII:8SSC91326P) 		DONEPEZIL HYDROCHLORIDE23 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2208 (4000 MPA.S)(UNII: 39J80LT57T)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYVINYL ALCOHOL(UNII: 532B59J990)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
Product Characteristics
Color white Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code T004
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24979-004-0630 in 1 BOTTLE Type 0: Not a Combination Product03/01/2015
2NDC:24979-004-031000 in 1 BOTTLE Type 0: Not a Combination Product03/01/2015
3NDC:24979-004-0790 in 1 BOTTLE Type 0: Not a Combination Product22/09/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203104 03/01/2015

LABELER - TWi Pharmaceuticals, Inc.(658402052)

REGISTRANT - TWi Pharmaceuticals, Inc.(658402052)

Establishment
Name Address ID/FEI Business Operations
TWi Pharmaceuticals, Inc. Zhongli Plant 658863394 manufacture(24979-004), analysis(24979-004), pack(24979-004)

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