FDA.reportPublic FDA data

Ceftriaxone

Product NDC
44567-700
11-digit product format
445670700
Labeler code
44567
Product ID
44567-700_eb48063c-c656-42d9-8733-841cd1b39a82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
ANDA065329
Marketing category
ANDA
Marketing start
2008-07-24
Substance
CEFTRIAXONE SODIUM
Active strength
500 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
Ceftriaxone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFTRIAXONE SODIUM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii023Z5BR09K
Rxcui1665005, 1665021, 1665046

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
67ae10d0-6c6a-4d52-a629-da83321859b9Product name320190201
01b0d089-049b-4c6d-8dfe-1bffad9be307Product name220180807
2d5083fe-71de-4fce-8d67-e9049cba775cProduct name120150107
1037f4ca-3bea-c9c4-2af4-fa6387b0e81eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44567-700-25Ceftriaxone25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION2519
44567-700-25Ceftriaxone1 in 1 VIALINJECTION, POWDER, FOR SOLUTION119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-700-25EA - Each44567-7006bbd1ff5-34ce-4626-8987-baf278d3afbf12013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFTRIAXONE SODIUMACTIVE INGREDIENT023Z5BR09KCEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]6
CEFTRIAXONEACTIVE MOIETY75J73V1629CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-700CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]19Current NDC, Legacy NDC, 2 package rows20250409_befd73ff-cb3b-4543-8a8e-bdb9b7fc1ff0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665021cefTRIAXone 1 GM InjectionPSNbefd73ff-cb3b-4543-8a8e-bdb9b7fc1ff019
1665046cefTRIAXone 2 GM InjectionPSNbefd73ff-cb3b-4543-8a8e-bdb9b7fc1ff019
1665005cefTRIAXone 500 MG InjectionPSNbefd73ff-cb3b-4543-8a8e-bdb9b7fc1ff019
1665021ceftriaxone 1000 MG InjectionSCDbefd73ff-cb3b-4543-8a8e-bdb9b7fc1ff019
1665046ceftriaxone 2000 MG InjectionSCDbefd73ff-cb3b-4543-8a8e-bdb9b7fc1ff019
1665005ceftriaxone 500 MG InjectionSCDbefd73ff-cb3b-4543-8a8e-bdb9b7fc1ff019
1665021ceftriaxone 1 GM (as ceftriaxone sodium) InjectionSYbefd73ff-cb3b-4543-8a8e-bdb9b7fc1ff019
1665046ceftriaxone 2 GM (as ceftriaxone sodium) InjectionSYbefd73ff-cb3b-4543-8a8e-bdb9b7fc1ff019
1665005ceftriaxone 500 MG (as ceftriaxone sodium) InjectionSYbefd73ff-cb3b-4543-8a8e-bdb9b7fc1ff019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44567-700-254456707002525 VIAL in 1 CARTON (44567-700-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL25 vial2008-07-240000-00-00NoNoCurrent