FDA.reportPublic FDA data

NDC 0143-9568-01 - Cefuroxime

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
0143-9568
Requested NDC
0143-9568-01
Package NDCs from labels
0143-9568-01, 0143-9568-25
Manufacturer
Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A
Effective date
2018-09-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cefuroxime - Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.AHikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A2018-09-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9568-01Cefuroxime1 in 1 VIALINJECTION, POWDER, FOR SOLUTION13
0143-9568-25Cefuroxime25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9568CEFUROXIME INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]3Current NDC, Legacy NDC, 2 package rows20220820_19902965-d2d6-433f-982d-0095014df4e8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9568-01EA - Each0143-9568994aed77-86a4-435d-93cf-101eb7178b0912015-08-04
0143-9568-25EA - Each0143-9568f360de72-b08b-41a4-8588-11e930197af912015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFUROXIME SODIUMACTIVE INGREDIENTR8A7M9MY61CEFUROXIME INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP]1
CEFUROXIMEACTIVE MOIETYO1R9FJ93EDCEFUROXIME INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP]1

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 1 of 1 ยท 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cefuroxime sodiumCEFUROXIME SODIUMSagent Pharmaceuticals0a145288-733a-4966-b7ae-dc96eb103d8c2025-03-27Warnings, Adverse reactionsExact identifier
rxcui: 1665444
rxcui: 1665449
unii: R8A7M9MY61
CefuroximeCEFUROXIMEHikma Pharmaceuticals USA Inc.79f5cf6f-a5e2-49a2-9704-fa1bd21338c32022-02-16Warnings, Adverse reactionsExact identifier
unii: R8A7M9MY61
Cefuroxime and DextroseCEFUROXIME AND DEXTROSEB. Braun Medical Inc.07170ee3-1a24-424f-a2a2-00bc92e98f852020-12-05Warnings, Adverse reactionsExact identifier
rxcui: 1665444
rxcui: 1665449
unii: R8A7M9MY61
CefuroximeCEFUROXIMEHikma Pharmaceuticals USA Inc.65daa2aa-cc4a-4eba-b7dc-7a151806865a2020-04-14Warnings, Adverse reactionsExact identifier
unii: R8A7M9MY61
CefuroximeCEFUROXIMEHikma Pharmaceuticals USA Inc.703cc338-c0b6-4a02-b8db-c27aeff181df2020-04-08Warnings, Adverse reactionsExact identifier
application number: ANDA065048
rxcui: 1665444
rxcui: 1665449
unii: R8A7M9MY61
CefuroximeCEFUROXIMEHikma Pharmaceuticals USA Inc.19902965-d2d6-433f-982d-0095014df4e82018-09-27Warnings, Adverse reactionsExact identifier
application number: ANDA065048
ndc (package): 0143-9568-25
ndc (package): 0143-9567-01
ndc (package): 0143-9567-25
ndc (package): 0143-9568-01
ndc (product): 0143-9567
ndc (product): 0143-9568
ndc11 (package): 00143956801
rxcui: 1665444
rxcui: 1665449
spl id: e43d5edd-fd78-43d3-b8d2-4b22b7541042
spl set id: 19902965-d2d6-433f-982d-0095014df4e8
unii: R8A7M9MY61

Reported adverse events (FAERS/openFDA)#

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