FDA.reportPublic FDA data

Cefuroxime sodium

Product NDC
25021-118
11-digit product format
250210118
Labeler code
25021
Product ID
25021-118_da170a9c-def7-432b-8999-701e7b878fe8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA064125
Marketing category
ANDA
Marketing start
2016-09-01
Substance
CEFUROXIME SODIUM
Active strength
750 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cefuroxime sodium
Listing expiration
2027-12-31

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
25021-118-10Cefuroxime sodium25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION2510
25021-118-10Cefuroxime sodium1 in 1 VIALINJECTION, POWDER, FOR SOLUTION110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-118-10EA - Each25021-1182cb89716-ed9a-4a05-b8ec-5cea831f9fa712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
cefuroxime sodiumACTIVE INGREDIENTR8A7M9MY61CEFUROXIME SODIUM INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]3
cefuroximeACTIVE MOIETYO1R9FJ93EDCEFUROXIME SODIUM INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-118CEFUROXIME SODIUM INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]9Current NDC, Legacy NDC, 2 package rows20250304_0a145288-733a-4966-b7ae-dc96eb103d8c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665444cefuroxime 1.5 GM InjectionPSN0a145288-733a-4966-b7ae-dc96eb103d8c10
1665449cefuroxime 750 MG InjectionPSN0a145288-733a-4966-b7ae-dc96eb103d8c10
1665444cefuroxime 1500 MG InjectionSCD0a145288-733a-4966-b7ae-dc96eb103d8c10
1665449cefuroxime 750 MG InjectionSCD0a145288-733a-4966-b7ae-dc96eb103d8c10
1665444cefuroxime 1.5 GM InjectionSY0a145288-733a-4966-b7ae-dc96eb103d8c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-118-102502101181025 VIAL in 1 CARTON (25021-118-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL25 vial2016-09-010000-00-00NoNoCurrent