FDA.reportPublic FDA data

Cefoxitin and Dextrose

Product NDC
0264-3123
11-digit product format
002643123
Labeler code
0264
Product ID
0264-3123_0cca0e6a-3047-4142-af33-d9b98efe85b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFOXITIN SODIUM
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
Application
NDA065214
Marketing category
NDA
Marketing start
2006-03-10
Substance
CEFOXITIN SODIUM
Active strength
1 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
Cefoxitin and Dextrose
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFOXITIN SODIUM1 g/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ68050H03T
Rxcui1665102, 1665107

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
674c093f-2e56-4442-b936-d876c9ac5966Product name120160111
33228014-863e-d9a4-2fc1-b5fe1bf2d490Product name120140508
cd1ea622-6dd0-ac04-3600-f4b6f14160ccProduct name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0264-3123-11Cefoxitin and Dextrose50 mL in 1 CONTAINERINJECTION, SOLUTION5023
0264-3123-11Cefoxitin and Dextrose24 in 1 CASEINJECTION, SOLUTION2423

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-3123-11EA - Each0264-3123897e8b5d-fae3-4ab4-bbdd-2778f5ef34d812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFOXITIN SODIUMACTIVE INGREDIENTQ68050H03TCEFOXITIN AND DEXTROSE (CEFOXITIN SODIUM) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]16
CEFOXITINACTIVE MOIETY6OEV9DX57YCEFOXITIN AND DEXTROSE (CEFOXITIN SODIUM) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]16
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2CEFOXITIN AND DEXTROSE (CEFOXITIN SODIUM) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]16
WATERINACTIVE INGREDIENT059QF0KO0RCEFOXITIN AND DEXTROSE (CEFOXITIN SODIUM) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0264-3123CEFOXITIN AND DEXTROSE (CEFOXITIN SODIUM) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]23Current NDC, Legacy NDC, 2 package rows20221027_6c7e9485-1ede-411c-8c46-911439332864.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665102cefOXitin 1 GM InjectionPSN6c7e9485-1ede-411c-8c46-91143933286423
1665107cefOXitin 2 GM InjectionPSN6c7e9485-1ede-411c-8c46-91143933286423
1665102cefoxitin 1000 MG InjectionSCD6c7e9485-1ede-411c-8c46-91143933286423
1665107cefoxitin 2000 MG InjectionSCD6c7e9485-1ede-411c-8c46-91143933286423
1665102cefoxitin (as cefoxitin sodium) 1000 MG InjectionSY6c7e9485-1ede-411c-8c46-91143933286423
1665107cefoxitin (as cefoxitin sodium) 2000 MG InjectionSY6c7e9485-1ede-411c-8c46-91143933286423
1665102cefoxitin 1 GM InjectionSY6c7e9485-1ede-411c-8c46-91143933286423
1665107cefoxitin 2 GM InjectionSY6c7e9485-1ede-411c-8c46-91143933286423

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0264-3123-110026431231124 CONTAINER in 1 CASE (0264-3123-11) / 50 mL in 1 CONTAINER24 container2006-03-100000-00-00NoNoCurrent