Aripiprazole (Page 12 of 12)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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ARIPIPRAZOLE aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-3471(NDC:16714-142)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE (ARIPIPRAZOLE) ARIPIPRAZOLE 5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
FD&C BLUE NO. 2
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color blue Score no score
Shape RECTANGLE Size 8mm
Flavor Imprint Code I;95
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-3471-3 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205064 10/01/2020
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 relabel (68071-3471)

Revised: 07/2023 NuCare Pharmaceuticals,Inc.

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