Dipyridamole

Product NDC
0115-1070
11-digit product format
001151070
Labeler code
0115
Product ID
0115-1070_02250a0f-40e1-4f73-8ead-1be26f78edc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIPYRIDAMOLE
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA040782
Marketing category
ANDA
Marketing start
2021-08-30
Substance
DIPYRIDAMOLE
Active strength
25 mg/1
Pharmacologic classes
Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dipyridamole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPYRIDAMOLE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64ALC7F90C
Rxcui197622, 309952, 309955

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
3285f096-1048-1647-9b36-a2e0f5b56c6cProduct name120140508
9ab2f788-fb50-9b8e-e14c-49841b1b5968Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-1070-01Dipyridamole100 in 1 BOTTLETABLET1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1070-01EA - Each0115-10707e9de0f8-df94-4ded-a3ca-9b1331957e4d12012-07-24
0115-1070-03EA - Each0115-107046a7ff48-aee9-43d6-9bdb-c651b306ae5712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPYRIDAMOLEACTIVE INGREDIENT64ALC7F90CDIPYRIDAMOLE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]3
DIPYRIDAMOLEACTIVE MOIETY64ALC7F90CDIPYRIDAMOLE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIPYRIDAMOLE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIPYRIDAMOLE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIPYRIDAMOLE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADIPYRIDAMOLE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EDIPYRIDAMOLE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIPYRIDAMOLE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DIPYRIDAMOLE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIPYRIDAMOLE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UDIPYRIDAMOLE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIPYRIDAMOLE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1070DIPYRIDAMOLE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]7Current NDC, Legacy NDC, 1 package rows20230418_a18b2af5-7c4a-4b7f-92c7-8a76e34da373.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309952dipyridamole 25 MG Oral TabletPSNa18b2af5-7c4a-4b7f-92c7-8a76e34da3738
197622dipyridamole 50 MG Oral TabletPSNa18b2af5-7c4a-4b7f-92c7-8a76e34da3738
309955dipyridamole 75 MG Oral TabletPSNa18b2af5-7c4a-4b7f-92c7-8a76e34da3738
309952dipyridamole 25 MG Oral TabletSCDa18b2af5-7c4a-4b7f-92c7-8a76e34da3738
197622dipyridamole 50 MG Oral TabletSCDa18b2af5-7c4a-4b7f-92c7-8a76e34da3738
309955dipyridamole 75 MG Oral TabletSCDa18b2af5-7c4a-4b7f-92c7-8a76e34da3738

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-1070-0100115107001100 TABLET in 1 BOTTLE (0115-1070-01) 100 tablet2021-08-300000-00-00NoNoCurrent