FDA.reportPublic FDA data

Ceftriaxone Sodium

Product NDC
50090-0944
11-digit product format
500900944
Labeler code
50090
Product ID
50090-0944_aec67c2e-94ef-4be6-afb1-d5c47bbdfad1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
A-S Medication Solutions
Application
ANDA065169
Marketing category
ANDA
Marketing start
2005-05-09
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 Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFTRIAXONE SODIUM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii023Z5BR09K
Rxcui1665005

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0944-02023-02-06C16284748780-1f386c649-bf97-0266-e053-dadaa90a7c1aCeftriaxone for Injection, USP
50090-0944-02023-01-30C16284748780-1f386c649-bf97-0266-e053-dadaa90a7c1aCeftriaxone for Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0944-0Ceftriaxone Sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1018
50090-0944-0Ceftriaxone Sodium1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0944-0EA - Each50090-0944703dd746-789e-43ed-8a16-59a7c0180ebd12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0944CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [A-S MEDICATION SOLUTIONS]18Current NDC, Legacy NDC, 2 package rows20240329_b642877e-0d36-4218-afe9-0a39f35b571d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665005cefTRIAXone 500 MG InjectionPSNb642877e-0d36-4218-afe9-0a39f35b571d18
1665005ceftriaxone 500 MG InjectionSCDb642877e-0d36-4218-afe9-0a39f35b571d18
1665005ceftriaxone 500 MG (as ceftriaxone sodium) InjectionSYb642877e-0d36-4218-afe9-0a39f35b571d18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0944-05009009440010 VIAL, SINGLE-USE in 1 CARTON (50090-0944-0) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE2014-11-280000-00-00NoNoCurrent