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 8 of 11 · 215 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
D02 DIGESTIVE DRAINAGEALOE, ACTIVATED CHARCOAL, COLCHICUM AUTUMNALE BULB, COLLINSONIA CANADENSIS ROOT, CUCURBITA PEPO FLOWER, DRYOPTERIS FILIX-MAS ROOT, INDOLE, SKIM MILK, LYCOPODIUM CLAVATUM SPORE, ACHILLEA MILLEFOLIUM, SODIUM SULFATE, FRANGULA PURSHIANA BARK, SCROPHULARIA NODOSA, SKATOLE, TARAXACUM OFFICINALE, TARTARIC ACIDApex Energetics Inc.ba8734bf-920c-0ce4-e053-2a95a90a07052024-01-08WarningsExact identifier
unii: W4888I119H
F02 ANGR-FLXADELHEID AQUA, ARSENICUM ALBUM, BIG SAGEBRUSH, BOS TAURUS LIVER, GALLBLADDER, BRIZA MAXIMA, CALENDULA OFFICINALIS, CAYENNE, CHAMOMILE , CHICORY , GARLIC, ENGLISH HOLLY , EUROPEAN BEECH , FORKING LARKSPUR , GERMAN CHAMOMILE , IMPATIENS GLANDULIFERA , JUGLANS REGIA , LILIUM TIGRINUM, MORNING GLORY, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, NUX VOMICA, PINUS SYLVESTRIS , REDWOOD, RUBBER RABBITBRUSH, SEPIA, TOLMIE STAR TULIP, VERBENA OFFICINALIS , VITIS VINIFERA , WATERMELON, WHITE WILLOW , YELLOW STAR THISTLEApex Energetics Inc.bc7c2bf3-8b0d-766f-e053-2a95a90ad34c2024-01-08WarningsExact identifier
unii: 059QF0KO0R
F09 LTGOADELHEID AQUA, AGRIMONY, MALUS SYLVESTRIS, ARSENICUM ALBUM, FILAREE, HEATHER, HORSE CHESTNUT, LACHESIS MUTUS, NASTURTIUM, RED HORSE CHESTNUT, SEPIA, SILICEA, STRAMONIUM, VERBENA OFFICINALISApex Energetics Inc.bd1e652f-b3a4-c5bd-e053-2995a90ae03f2024-01-08WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.b56ef662-fec2-4d94-e053-2995a90aba2b2024-01-06WarningsExact identifier
unii: 059QF0KO0R
Aspirin and DipyridamoleASPIRIN AND DIPYRIDAMOLENorthStar Rx LLC465bbdac-a483-689a-811f-32923ea99fa72023-12-26Warnings, Adverse reactionsExact identifier
unii: 64ALC7F90C
Leader Eye WashPURIFIED WATERCardinal Health8d3ad11f-1945-f838-e053-2995a90a7aa52023-12-23WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERJiangxi Zhenmei Biological Technology Co.,Ltdc68795b8-bf68-0d01-e053-2a95a90abebb2023-12-04WarningsExact identifier
unii: 059QF0KO0R
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643994f-4e13-4572-e053-2991aa0a5b782023-11-14Exact identifier
unii: QTT17582CB
Muriaticum acidumHYDROCHLORIC ACIDBoiron6907bbfe-caa5-2ce4-e053-2991aa0ade8d2023-11-14Exact identifier
unii: QTT17582CB
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643c518-13b2-658a-e053-2a91aa0ac5ed2023-11-14Exact identifier
unii: QTT17582CB
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643e30e-1f47-09f1-e053-2991aa0ac2de2023-11-14Exact identifier
unii: QTT17582CB
CV TOXCOCHLEARIA ARMORACIA, ECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PROPOLIS, GLANDULA SUPRARENALIS BOVINE, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, MORBILLINUM, POLIOMYELITIS NOSODE, HEPATITIS B NOSODE, COXSACKIE B1 NOSODE, CYTOMEGALOVIRUS NOSODE, COXSACKIE B4 NOSODE, EPSTEIN BARR VIRUS NOSODEBioActive Nutritional, Inc.8ef2fb5c-1b24-46a1-8d21-a78ce0a34a872023-11-07WarningsExact identifier
unii: QTT17582CB
Ahh SleepCOFFEA CRUDAMicro Balance Health Products08ea860f-0183-8ce8-e063-6394a90a582b2023-10-30WarningsExact identifier
unii: QTT17582CB
Stomach Enzyme FormulaBETAINUM MURIATICUM, MURIATICUM ACIDUM, NATRUM PHOSPHORICUM, PANCREAS SUIS, STOMACH (SUIS) SYMPHYTUM OFFICINALE, PEPSINUMNutritional Specialties, Inc.992e6f61-abc9-4146-a9da-5ada4a627aa72023-10-04WarningsExact identifier
unii: QTT17582CB
DipyridamoleDIPYRIDAMOLEZydus Pharmaceuticals USA Inc.004bada0-dbf7-4a94-8792-6833d7eeda2b2023-09-16Adverse reactionsExact identifier
unii: 64ALC7F90C
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedAZELAIC ACID, SALICYLIC ACIDANUBIS COSMETICS SLebf3153d-30f5-54e4-e053-2995a90a74b12023-09-05WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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