FDA.reportPublic FDA data

Cefuroxime

Product NDC
0143-9569
11-digit product format
001439569
Labeler code
0143
Product ID
0143-9569_a44c47cd-1104-4275-b859-d7ed2af78b8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065046
Marketing category
ANDA
Marketing start
2004-01-09
Substance
CEFUROXIME SODIUM
Active strength
7.5 g/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cefuroxime
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFUROXIME SODIUM7.5 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR8A7M9MY61
Rxcui309101

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba66f2a7-7ba5-e81a-8863-a38bd5c2e969Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9569-01Cefuroxime1 in 1 VIALINJECTION, POWDER, FOR SOLUTION15
0143-9569-10Cefuroxime10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9569-01EA - Each0143-9569352610a4-7e19-4e08-af64-980597f5ce3d12015-08-04
0143-9569-10EA - Each0143-956955cc1079-7314-4503-aa6c-1cda2a7b6dbf12015-08-04

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9569CEFUROXIME INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 2 package rows20220217_79f5cf6f-a5e2-49a2-9704-fa1bd21338c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309101cefuroxime 95 MG/ML Injectable SolutionPSN79f5cf6f-a5e2-49a2-9704-fa1bd21338c35
309101cefuroxime 95 MG/ML Injectable SolutionSCD79f5cf6f-a5e2-49a2-9704-fa1bd21338c35
309101cefuroxime 7.5 GM per 77 ML Injectable SolutionSY79f5cf6f-a5e2-49a2-9704-fa1bd21338c35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9569-01001439569011 in 1 VIALHistorical
0143-9569-100014395691010 VIAL in 1 CARTON (0143-9569-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9569-01) 10 vial2004-01-090000-00-00NoNoCurrent