FDA.reportPublic FDA data

Cefuroxime and Dextrose

Product NDC
0264-3114
11-digit product format
002643114
Labeler code
0264
Product ID
0264-3114_6874a295-7ec7-4822-9d04-4dd9932b4546
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFUROXIME AND DEXTROSE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
Application
NDA050780
Marketing category
NDA
Marketing start
2001-02-21
Substance
CEFUROXIME SODIUM
Active strength
1.5 g/50mL
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 and Dextrose
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFUROXIME SODIUM1.5 g/50mL

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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0264-3114-11Cefuroxime and Dextrose50 mL in 1 CONTAINERINJECTION, SOLUTION5016
0264-3114-11Cefuroxime and Dextrose24 in 1 CASEINJECTION, SOLUTION2416

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-3114-11EA - Each0264-3114b43e5214-885e-46cc-8f7b-063c0efca1b012012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0264-3114CEFUROXIME AND DEXTROSE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]16Current NDC, Legacy NDC, 2 package rows20201219_07170ee3-1a24-424f-a2a2-00bc92e98f85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665444cefuroxime 1.5 GM InjectionPSN07170ee3-1a24-424f-a2a2-00bc92e98f8516
1665449cefuroxime 750 MG InjectionPSN07170ee3-1a24-424f-a2a2-00bc92e98f8516
1665444cefuroxime 1500 MG InjectionSCD07170ee3-1a24-424f-a2a2-00bc92e98f8516
1665449cefuroxime 750 MG InjectionSCD07170ee3-1a24-424f-a2a2-00bc92e98f8516
1665444cefuroxime 1.5 GM InjectionSY07170ee3-1a24-424f-a2a2-00bc92e98f8516

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0264-3114-110026431141124 CONTAINER in 1 CASE (0264-3114-11) / 50 mL in 1 CONTAINER24 container2001-02-210000-00-00NoNoCurrent