Aggrenox (Page 7 of 7)

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Aggrenox 25mg/200mg Label
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AGGRENOX aspirin and dipyridamole capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-656(NDC:00597-001)
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
aluminum stearate
silicon dioxide
starch, corn
hypromellose phthalate (31% phthalate, 170 cst)
lactose monohydrate
methacrylic acid — methyl methacrylate copolymer (1:1)
cellulose, microcrystalline
stearic acid
tartaric acid
titanium dioxide
ferric oxide red
ferric oxide yellow
Product Characteristics
Color RED (red) , WHITE (ivory) Score no score
Shape CAPSULE (capsule) Size 24mm
Flavor Imprint Code BI;01A
# Item Code Package Description Multilevel Packaging
1 NDC:21695-656-60 60 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020884 12/19/1999
Labeler — Rebel Distributors Corp. (118802834)
Name Address ID/FEI Operations
Rebel Distributors Corp. 118802834 RELABEL, REPACK

Revised: 09/2010 Rebel Distributors Corp.

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