FDA.reportPublic FDA data

Ceftriaxone Sodium

Product NDC
60505-6150
11-digit product format
605056150
Labeler code
60505
Product ID
60505-6150_7e33cb12-f475-450f-9df3-9158dea19877
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Apotex Corp.
Application
ANDA209218
Marketing category
ANDA
Marketing start
2019-01-21
Substance
CEFTRIAXONE SODIUM
Active strength
10 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 Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFTRIAXONE SODIUM10 g/1

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
60505-6150-5Ceftriaxone Sodium1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION16
60505-6150-5Ceftriaxone Sodium1 in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, FOR SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6150-5EA - Each60505-61508b97fc92-390c-4179-a970-a1a9827158ac12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6150CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [APOTEX CORP.]6Current NDC, Legacy NDC, 2 package rows20230130_ac03a72c-0e35-40f9-b7fc-081badb5f19c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309090cefTRIAXone 100 MG/ML Injectable SolutionPSNac03a72c-0e35-40f9-b7fc-081badb5f19c6
309090ceftriaxone 100 MG/ML Injectable SolutionSCDac03a72c-0e35-40f9-b7fc-081badb5f19c6
309090ceftriaxone (as ceftriaxone sodium) 10 GM per 100 ML Injectable SolutionSYac03a72c-0e35-40f9-b7fc-081badb5f19c6
309090ceftriaxone (as ceftriaxone sodium) 100 GM per 1000 ML Injectable SolutionSYac03a72c-0e35-40f9-b7fc-081badb5f19c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-6150-5605056150051 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (60505-6150-5) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE2019-01-210000-00-00NoNoCurrent