FDA.reportPublic FDA data

Dipyridamole

Product NDC
0641-2569
11-digit product format
006412569
Labeler code
0641
Product ID
0641-2569_23eb358a-2250-4a58-a8b7-735beaab1f83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dipyridamole
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA074521
Marketing category
ANDA
Marketing start
1996-10-18
Substance
DIPYRIDAMOLE
Active strength
5 mg/mL
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
DIPYRIDAMOLE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64ALC7F90C
Rxcui309953

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
3285f096-1048-1647-9b36-a2e0f5b56c6cProduct name120140508
9ab2f788-fb50-9b8e-e14c-49841b1b5968Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-2569-41Dipyridamole10 mL in 1 VIALINJECTION108
0641-2569-44Dipyridamole5 in 1 CARTONINJECTION58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-2569-41ML - Milliliter0641-2569b9fc396b-a15d-4f93-bfed-f3c2fe7d236612012-07-24
0641-2569-44ML - Milliliter0641-25696520a2eb-313b-4fce-8955-4dbb471e6f7312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPYRIDAMOLEACTIVE INGREDIENT64ALC7F90CDIPYRIDAMOLE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
DIPYRIDAMOLEACTIVE MOIETY64ALC7F90CDIPYRIDAMOLE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDIPYRIDAMOLE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9DIPYRIDAMOLE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HDIPYRIDAMOLE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
WATERINACTIVE INGREDIENT059QF0KO0RDIPYRIDAMOLE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-2569DIPYRIDAMOLE INJECTION [HIKMA PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 2 package rows20240410_6093dcd9-82d2-414f-8507-eda22c14f626.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309953dipyridamole 50 MG in 10 ML InjectionPSN6093dcd9-82d2-414f-8507-eda22c14f6268
30995310 ML dipyridamole 5 MG/ML InjectionSCD6093dcd9-82d2-414f-8507-eda22c14f6268
309953dipyridamole 50 MG per 10 ML InjectionSY6093dcd9-82d2-414f-8507-eda22c14f6268
309953dipyridamole 50 MG in 10 ML InjectionPSN1a2c0a9a-c637-4485-ad4b-0b6d0b05fa205
30995310 ML dipyridamole 5 MG/ML InjectionSCD1a2c0a9a-c637-4485-ad4b-0b6d0b05fa205
309953dipyridamole 50 MG per 10 ML InjectionSY1a2c0a9a-c637-4485-ad4b-0b6d0b05fa205
309953dipyridamole 50 MG in 10 ML InjectionPSN9bd34108-9d98-c4ca-e053-2995a90a2bc83
30995310 ML dipyridamole 5 MG/ML InjectionSCD9bd34108-9d98-c4ca-e053-2995a90a2bc83
309953dipyridamole 50 MG per 10 ML InjectionSY9bd34108-9d98-c4ca-e053-2995a90a2bc83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-2569-410064125694110 mL in 1 VIAL10 mlHistorical
0641-2569-44006412569445 VIAL in 1 CARTON (0641-2569-44) / 10 mL in 1 VIAL (0641-2569-41) 5 vial1996-10-180000-00-00NoNoCurrent