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 2 of 11 · 215 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDBM Private Limited540d11e3-e4a1-0ca2-e063-6394a90a3c262026-06-12WarningsExact identifier
unii: QTT17582CB
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DipyridamoleDIPYRIDAMOLEHikma Pharmaceuticals USA Inc.6093dcd9-82d2-414f-8507-eda22c14f6262026-05-20Warnings, Adverse reactionsExact identifier
application number: ANDA074521
ndc (package): 0641-2569-41
ndc (package): 0641-2569-44
ndc (product): 0641-2569
ndc11 (package): 00641256941
rxcui: 309953
spl id: 4c31b09f-7015-4534-afd6-5cb042792109
spl set id: 6093dcd9-82d2-414f-8507-eda22c14f626
unii: 64ALC7F90C
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
DipyridamoleDIPYRIDAMOLEREMEDYREPACK INC.226099e2-70bb-4b9b-bb52-c20fbca2aec52026-04-29Adverse reactionsExact identifier
unii: 64ALC7F90C
Joint Tonic R IIHARPAGOPHYTUM PROCUMBENS, SALIX ALBA, COLCHICUM AUTUMNALE, PINUS SYLVESTRIS, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARNICA MONTANA, GELSEMIUM SEMPERVIRENS, IRIS VERSICOLOR, LEDUM PALUSTRE, LESPEDEZA CAPITATA, RHUS TOX, SECALE CORNUTUM, SPIGELIA ANTHELMIA, SPIRAEA ULMARIA, TARTARICUM ACIDUMBioActive Nutritional, Inc.77afccf5-4e9c-45a1-8a6a-e686bcf22f162026-04-17WarningsExact identifier
unii: W4888I119H
DipyridamoleDIPYRIDAMOLEAmneal Pharmaceuticals of New York LLCa18b2af5-7c4a-4b7f-92c7-8a76e34da3732026-04-15Adverse reactionsExact identifier
unii: 64ALC7F90C
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Skin Irritations and Itch ReliefAGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS.King Bio Inc.d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd2026-03-10WarningsExact identifier
unii: QTT17582CB
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Aspirin and Extended-Release DipyridamoleASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLEAvKAREc9a73ec9-e468-46a5-b2c1-99f1f15365852026-01-14Warnings, Adverse reactionsExact identifier
unii: 64ALC7F90C

Reported adverse events (FAERS/openFDA)#

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