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 5 of 11 · 215 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: W4888I119H
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLEASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLEMicro Labs Limited111a4f6a-c3e4-43e2-8f0e-8c72f71cddb22025-04-23Warnings, Adverse reactionsExact identifier
unii: 64ALC7F90C
Bestmade Natural Products BM182 PelletsGRAPHITES, HEPAR SULF, MERC SOL, MURIATIC ACIDBestmade Natural Products3242e013-2952-2b56-e063-6294a90a16932025-04-08WarningsExact identifier
unii: QTT17582CB
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM62AMMONIUM BENZOICUM, AURUM MUR, CALC ARS, CARDUUS MAR, CROTALUS HORRIDUS, MURIATIC ACID, NUX VOM, PHOSPHORUS, VIPERABestmade Natural Products2ce99cb7-fe9e-5da2-e063-6294a90afc4e2025-01-30WarningsExact identifier
unii: QTT17582CB
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLEASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLEBryant Ranch Prepack4f0ac35b-dc0d-4a73-92d1-a6153ff61fea2025-01-28Warnings, Adverse reactionsExact identifier
unii: 64ALC7F90C
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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