Aggrenox
These highlights do not include all the information needed to use Aggrenox Capsules safely and effectively. See full prescribing information for Aggrenox Capsules. AGGRENOX® (aspirin/extended-release dipyridamole) Capsules Initial U.S. Approval: 1999
Approved
Approval ID
6473563d-b4df-4434-a74e-f8fa3cb9994f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 1, 2010
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
aspirin and dipyridamole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-656
Application NumberNDA020884
Product Classification
M
Marketing Category
C73594
G
Generic Name
aspirin and dipyridamole
Product Specifications
Route of AdministrationORAL
Effective DateOctober 15, 2009
FDA Product Classification
INGREDIENTS (23)
aspirinActive
Quantity: 25 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
acaciaInactive
Code: 5C5403N26O
Classification: IACT
aluminum stearateInactive
Code: U6XF9NP8HM
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
dipyridamoleActive
Quantity: 200 mg in 1 1
Code: 64ALC7F90C
Classification: ACTIB
dimethiconeInactive
Code: 92RU3N3Y1O
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
hypromelloseInactive
Code: 3NXW29V3WO
Classification: IACT
hypromellose phthalate (31% phthalate, 170 cst)Inactive
Code: 8LDD2V82F5
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
methacrylic acid - methyl methacrylate copolymer (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
sucroseInactive
Code: C151H8M554
Classification: IACT
tartaric acidInactive
Code: W4888I119H
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT