FDA.reportPublic FDA data

NDC 0641-2569-41 - Dipyridamole

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0641-2569
Requested NDC
0641-2569-41
Package NDCs from labels
0641-2569-41, 0641-2569-44
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2026-05-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dipyridamole Injection, USP Rx onlyHikma Pharmaceuticals USA Inc.2026-05-20HUMAN PRESCRIPTION DRUG LABEL
Dipyridamole 5 mg/mL Injection, USP 10 mL Single Dose VialHenry Schein, Inc.2025-10-30HUMAN PRESCRIPTION DRUG LABEL
DIPYRIDAMOLE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2025-01-08HUMAN PRESCRIPTION DRUG LABEL
Dipyridamole - General Injectables & Vaccines, IncGeneral Injectables & Vaccines, Inc2022-06-15HUMAN PRESCRIPTION DRUG LABEL
Dipyridamole 5 mg/mL Injection, USP 10 mL Single Dose VialHenry Schein, Inc.2022-01-10HUMAN PRESCRIPTION DRUG LABEL
Dipyridamole 5 mg/mL Injection, USP 10 mL Single Dose VialHenry Schein, Inc.2022-01-10HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

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 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 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
DipyridamoleACTIVE INGREDIENT64ALC7F90CDIPYRIDAMOLE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]2
DipyridamoleACTIVE MOIETY64ALC7F90CDIPYRIDAMOLE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 11 · 215 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DipyridamoleDIPYRIDAMOLEHenry Schein, Inc.1a2c0a9a-c637-4485-ad4b-0b6d0b05fa202025-10-30Warnings, Adverse reactionsExact identifier
application number: ANDA074521
ndc (package): 0404-9852-10
ndc (product): 0404-9852
rxcui: 309953
spl id: aa6a1a43-815a-4c9a-9720-d3c04bad6e4d
spl set id: 1a2c0a9a-c637-4485-ad4b-0b6d0b05fa20
unii: 64ALC7F90C
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.