FDA.reportPublic FDA data

Dipyridamole

Product NDC
68382-189
11-digit product format
683820189
Labeler code
68382
Product ID
68382-189_8b638b19-214a-4a58-a336-656d690130e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dipyridamole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA040874
Marketing category
ANDA
Marketing start
2008-05-22
Substance
DIPYRIDAMOLE
Active strength
75 mg/1
Pharmacologic classes
Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dipyridamole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPYRIDAMOLE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64ALC7F90C
Rxcui197622, 309952, 309955

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
3285f096-1048-1647-9b36-a2e0f5b56c6cProduct name120140508
9ab2f788-fb50-9b8e-e14c-49841b1b5968Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-189-01Dipyridamole100 in 1 BOTTLETABLET, FILM COATED10010
68382-189-05Dipyridamole500 in 1 BOTTLETABLET, FILM COATED50010
68382-189-10Dipyridamole1000 in 1 BOTTLETABLET, FILM COATED100010
68382-189-77Dipyridamole10 in 1 BLISTER PACKTABLET, FILM COATED1010
68382-189-77Dipyridamole10 in 1 CARTONTABLET, FILM COATED1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-189-01EA - Each68382-189da1939bf-cb62-4eb2-8d9c-85782c9c44c312012-07-24
68382-189-05EA - Each68382-1897c1e603b-4214-4e2f-b768-74d657023f2212012-07-24
68382-189-10EA - Each68382-189d7db1445-fd38-492a-9e47-55ab5ca6115d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPYRIDAMOLEACTIVE INGREDIENT64ALC7F90CDIPYRIDAMOLE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]2
DIPYRIDAMOLEACTIVE MOIETY64ALC7F90CDIPYRIDAMOLE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDIPYRIDAMOLE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIPYRIDAMOLE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIPYRIDAMOLE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIPYRIDAMOLE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ADIPYRIDAMOLE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EDIPYRIDAMOLE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIPYRIDAMOLE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIPYRIDAMOLE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-189DIPYRIDAMOLE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]10Current NDC, Legacy NDC, 5 package rows20230917_004bada0-dbf7-4a94-8792-6833d7eeda2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309952dipyridamole 25 MG Oral TabletPSN004bada0-dbf7-4a94-8792-6833d7eeda2b10
197622dipyridamole 50 MG Oral TabletPSN004bada0-dbf7-4a94-8792-6833d7eeda2b10
309955dipyridamole 75 MG Oral TabletPSN004bada0-dbf7-4a94-8792-6833d7eeda2b10
309952dipyridamole 25 MG Oral TabletSCD004bada0-dbf7-4a94-8792-6833d7eeda2b10
197622dipyridamole 50 MG Oral TabletSCD004bada0-dbf7-4a94-8792-6833d7eeda2b10
309955dipyridamole 75 MG Oral TabletSCD004bada0-dbf7-4a94-8792-6833d7eeda2b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-189-0168382018901100 TABLET, FILM COATED in 1 BOTTLE (68382-189-01) 2008-05-220000-00-00NoNoCurrent
68382-189-0568382018905500 TABLET, FILM COATED in 1 BOTTLE (68382-189-05) 2008-05-220000-00-00NoNoCurrent
68382-189-10683820189101000 TABLET, FILM COATED in 1 BOTTLE (68382-189-10) 2008-05-220000-00-00NoNoCurrent
68382-189-776838201897710 BLISTER PACK in 1 CARTON (68382-189-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2008-05-220000-00-00NoNoCurrent