FDA.reportPublic FDA data

Ceftriaxone

Product NDC
63323-346
11-digit product format
633230346
Labeler code
63323
Product ID
63323-346_27777645-c5ae-4c89-abaf-ddb62dc7b859
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA065329
Marketing category
ANDA
Marketing start
2011-06-20
Substance
CEFTRIAXONE SODIUM
Active strength
1 g/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 SODIUM1 g/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
63323-346-01Ceftriaxone1 in 1 VIALINJECTION, POWDER, FOR SOLUTION16
63323-346-10Ceftriaxone25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-346-01EA - Each63323-346958072ed-1f1b-4ffb-95e1-02bc390ff67612024-04-05
63323-346-10EA - Each63323-34695eca02f-82c1-4c6f-9e98-6d7ab28be09b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFTRIAXONE SODIUMACTIVE INGREDIENT023Z5BR09KCEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [APP PHARMACEUTICALS , LLC]1
CEFTRIAXONEACTIVE MOIETY75J73V1629CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [APP PHARMACEUTICALS , LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-346CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 2 package rows20231021_7ea1db43-40fa-417b-8911-ae98092070a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665021cefTRIAXone 1 GM InjectionPSN7ea1db43-40fa-417b-8911-ae98092070a06
1665046cefTRIAXone 2 GM InjectionPSN7ea1db43-40fa-417b-8911-ae98092070a06
1665005cefTRIAXone 500 MG InjectionPSN7ea1db43-40fa-417b-8911-ae98092070a06
1665021ceftriaxone 1000 MG InjectionSCD7ea1db43-40fa-417b-8911-ae98092070a06
1665046ceftriaxone 2000 MG InjectionSCD7ea1db43-40fa-417b-8911-ae98092070a06
1665005ceftriaxone 500 MG InjectionSCD7ea1db43-40fa-417b-8911-ae98092070a06
1665021ceftriaxone 1 GM (as ceftriaxone sodium) InjectionSY7ea1db43-40fa-417b-8911-ae98092070a06
1665046ceftriaxone 2 GM (as ceftriaxone sodium) InjectionSY7ea1db43-40fa-417b-8911-ae98092070a06
1665005ceftriaxone 500 MG (as ceftriaxone sodium) InjectionSY7ea1db43-40fa-417b-8911-ae98092070a06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-346-01633230346011 in 1 VIALHistorical
63323-346-106332303461025 VIAL in 1 CARTON (63323-346-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (63323-346-01) 25 vial2011-06-200000-00-00NoNoCurrent