FDA.reportPublic FDA data

Ceftriaxone

Product NDC
44567-703
11-digit product format
445670703
Labeler code
44567
Product ID
44567-703_25b246f3-2324-45b8-94f3-657774b7cb62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
ANDA065328
Marketing category
ANDA
Marketing start
2008-07-24
Substance
CEFTRIAXONE SODIUM
Active strength
10 g/100mL
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 SODIUM10 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii023Z5BR09K
Rxcui309090

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
44567-703-01Ceftriaxone100 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION10013
44567-703-01Ceftriaxone1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-703-01EA - Each44567-703f2ee6643-5d2d-4288-9e51-924c26aa17c012013-05-02

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
44567-703CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]13Current NDC, Legacy NDC, 2 package rows20231019_86ec0a92-a552-4a6d-9125-a54f95e43392.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309090cefTRIAXone 100 MG/ML Injectable SolutionPSN86ec0a92-a552-4a6d-9125-a54f95e4339213
309090ceftriaxone 100 MG/ML Injectable SolutionSCD86ec0a92-a552-4a6d-9125-a54f95e4339213
309090ceftriaxone (as ceftriaxone sodium) 10 GM per 100 ML Injectable SolutionSY86ec0a92-a552-4a6d-9125-a54f95e4339213
309090ceftriaxone (as ceftriaxone sodium) 100 GM per 1000 ML Injectable SolutionSY86ec0a92-a552-4a6d-9125-a54f95e4339213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44567-703-01445670703011 VIAL in 1 CARTON (44567-703-01) / 100 mL in 1 VIAL1 vial2019-04-050000-00-00NoNoCurrent