Aspirin and Extended-Release Dipyridamole (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

60 Capsules
(click image for full-size original)
ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE aspirin and extended-release dipyridamole capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-596
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 25 mg
DIPYRIDAMOLE (DIPYRIDAMOLE) DIPYRIDAMOLE 200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
HYPROMELLOSES
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)
LACTOSE MONOHYDRATE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
STEARIC ACID
SUCROSE
TALC
TARTARIC ACID
TRIETHYL CITRATE
TRIACETIN
D&C YELLOW NO. 10
GELATIN
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
WATER
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
BUTYL ALCOHOL
FD&C RED NO. 40
ISOPROPYL ALCOHOL
POVIDONE
PROPYLENE GLYCOL
SHELLAC
SODIUM HYDROXIDE
DIMETHICONE
Product Characteristics
Color red (red-opaque) , yellow (yellow-opaque) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code AN;596
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-596-06 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206392 03/28/2016
Labeler — Amneal Pharmaceuticals LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals of New York, LLC 123797875 analysis (65162-596), label (65162-596), manufacture (65162-596), pack (65162-596)

Revised: 06/2021 Amneal Pharmaceuticals LLC

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