Cefuroxime

Product NDC
0143-9568
11-digit product format
001439568
Labeler code
0143
Product ID
0143-9568_e43d5edd-fd78-43d3-b8d2-4b22b7541042
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065048
Marketing category
ANDA
Marketing start
2004-01-09
Substance
CEFUROXIME SODIUM
Active strength
750 mg/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 SODIUM750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR8A7M9MY61
Rxcui1665444, 1665449

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
0143-9568-01Cefuroxime1 in 1 VIALINJECTION, POWDER, FOR SOLUTION13
0143-9568-25Cefuroxime25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION253

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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665444cefuroxime 1.5 GM InjectionPSN19902965-d2d6-433f-982d-0095014df4e83
1665449cefuroxime 750 MG InjectionPSN19902965-d2d6-433f-982d-0095014df4e83
1665444cefuroxime 1500 MG InjectionSCD19902965-d2d6-433f-982d-0095014df4e83
1665449cefuroxime 750 MG InjectionSCD19902965-d2d6-433f-982d-0095014df4e83
1665444cefuroxime 1.5 GM InjectionSY19902965-d2d6-433f-982d-0095014df4e83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9568-01001439568011 in 1 VIALHistorical
0143-9568-250014395682525 VIAL in 1 CARTON (0143-9568-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9568-01) 25 vial2004-01-090000-00-00NoNoCurrent