FDA.reportPublic FDA data

CEFTRIAXONE AND DEXTROSE

Product NDC
0264-3155
11-digit product format
002643155
Labeler code
0264
Product ID
0264-3155_05bf8d04-202d-472f-94b5-4f5d9020f0c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFTRIAXONE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
Application
NDA050796
Marketing category
NDA
Marketing start
2005-04-20
Substance
CEFTRIAXONE SODIUM
Active strength
2 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
CEFTRIAXONE AND DEXTROSE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFTRIAXONE SODIUM2 g/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii023Z5BR09K
Rxcui1665021, 1665046

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
67ae10d0-6c6a-4d52-a629-da83321859b9Product name320190201
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
01b0d089-049b-4c6d-8dfe-1bffad9be307Product name220180807
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
2d5083fe-71de-4fce-8d67-e9049cba775cProduct name120150107
1037f4ca-3bea-c9c4-2af4-fa6387b0e81eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0264-3155-11CEFTRIAXONE AND DEXTROSE24 in 1 CASEINJECTION, SOLUTION2436
0264-3155-11CEFTRIAXONE AND DEXTROSE50 mL in 1 CONTAINERINJECTION, SOLUTION5036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-3155-11EA - Each0264-3155e688ca49-87cf-483d-9eeb-a331ea20d4e412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFTRIAXONE SODIUMACTIVE INGREDIENT023Z5BR09KCEFTRIAXONE AND DEXTROSE (CEFTRIAXONE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]23
CEFTRIAXONEACTIVE MOIETY75J73V1629CEFTRIAXONE AND DEXTROSE (CEFTRIAXONE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]23
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GCEFTRIAXONE AND DEXTROSE (CEFTRIAXONE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]23
WATERINACTIVE INGREDIENT059QF0KO0RCEFTRIAXONE AND DEXTROSE (CEFTRIAXONE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0264-3155CEFTRIAXONE AND DEXTROSE (CEFTRIAXONE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]36Current NDC, Legacy NDC, 2 package rows20220127_67153914-16bc-490d-82d7-638061618467.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665021cefTRIAXone 1 GM InjectionPSN67153914-16bc-490d-82d7-63806161846736
1665046cefTRIAXone 2 GM InjectionPSN67153914-16bc-490d-82d7-63806161846736
1665021ceftriaxone 1000 MG InjectionSCD67153914-16bc-490d-82d7-63806161846736
1665046ceftriaxone 2000 MG InjectionSCD67153914-16bc-490d-82d7-63806161846736
1665021ceftriaxone 1 GM (as ceftriaxone sodium) InjectionSY67153914-16bc-490d-82d7-63806161846736
1665046ceftriaxone 2 GM (as ceftriaxone sodium) InjectionSY67153914-16bc-490d-82d7-63806161846736

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0264-3155-110026431551124 CONTAINER in 1 CASE (0264-3155-11) / 50 mL in 1 CONTAINER24 container2005-04-200000-00-00NoNoCurrent