MedPath

Dipyridamole

DIPYRIDAMOLE Tablets USP

Approved
Approval ID

0a15a4d9-48cd-458c-ace9-f47c9e481eaf

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 15, 2012

Manufacturers
FDA

Carilion Materials Management

DUNS: 079239644

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Dipyridamole

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68151-2996
Application NumberNDA012836
Product Classification
M
Marketing Category
C73605
G
Generic Name
Dipyridamole
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2012
FDA Product Classification

INGREDIENTS (18)

D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
DIPYRIDAMOLEActive
Quantity: 25 mg in 1 1
Code: 64ALC7F90C
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT

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Dipyridamole - FDA Drug Approval Details