NDC Code(s) : 42571-274-60
Packager : Micro Labs Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLEASPIRIN and Extended-Release DIPYRIDAMOLE CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42571-274
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN(UNII: R16CO5Y76E)
(ASPIRIN - UNII:R16CO5Y76E) 		ASPIRIN25 mg
DIPYRIDAMOLE(UNII: 64ALC7F90C)
(DIPYRIDAMOLE - UNII:64ALC7F90C) 		DIPYRIDAMOLE200 mg
Inactive Ingredients
Ingredient Name Strength
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES(UNII: U72Q2I8C85)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE(UNII: FZ989GH94E)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TARTARIC ACID(UNII: W4888I119H)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
GELATIN(UNII: 2G86QN327L)
SHELLAC(UNII: MB5IUD6JUA)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
POLYVINYL ALCOHOL(UNII: 532B59J990)
AMMONIA(UNII: 5138Q19F1X)
Product Characteristics
Color red (red opaque colored cap and ivory opaque colored body) Score no score
Shape CAPSULE (capsule) Size 24 mm
Flavor Imprint Code M25
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42571-274-6060 in 1 BOTTLE Type 0: Not a Combination Product16/08/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209929 08/16/2021

LABELER - Micro Labs Limited(862174955)

Establishment
Name Address ID/FEI Business Operations
Micro Labs Limited 915793658 analysis(42571-274), label(42571-274), manufacture(42571-274), pack(42571-274)

PRINCIPAL DISPLAY PANEL

NDC 42571-274-60
Aspirin and
Extended-Release
Dipyridamole Capsules
25 mg/200 mg
Unit-of-use Container
Rx only
60 Capsules
MICRO LABS LIMITED


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