Cefuroxime

Product NDC
0143-9976
11-digit product format
001439976
Labeler code
0143
Product ID
0143-9976_5621cde0-74c5-45b2-8f76-329eb22b4a0a
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
750 mg/8mL
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 SODIUM750 mg/8mL

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
0143-9976-03Cefuroxime10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION108
0143-9976-91Cefuroxime82.5 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, FOR SOLUTION82.58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9976-03EA - Each0143-9976510e4821-e594-4557-95fe-f40c80c4508e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFUROXIME SODIUMACTIVE INGREDIENTR8A7M9MY61CEFUROXIME INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
CEFUROXIMEACTIVE MOIETYO1R9FJ93EDCEFUROXIME INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9976CEFUROXIME INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 2 package rows20220820_65daa2aa-cc4a-4eba-b7dc-7a151806865a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309101cefuroxime 95 MG/ML Injectable SolutionPSN65daa2aa-cc4a-4eba-b7dc-7a151806865a8
309101cefuroxime 95 MG/ML Injectable SolutionSCD65daa2aa-cc4a-4eba-b7dc-7a151806865a8
309101cefuroxime 7.5 GM per 77 ML Injectable SolutionSY65daa2aa-cc4a-4eba-b7dc-7a151806865a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9976-030014399760310 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0143-9976-03) / 82.5 mL in 1 VIAL, PHARMACY BULK PACKAGE (0143-9976-91) 2004-01-090000-00-00NoNoCurrent
0143-9976-910014399769182.5 mL in 1 VIAL, PHARMACY BULK PACKAGE82.5 mlHistorical