FDA.reportPublic FDA data

Ceftriaxone Sodium

Product NDC
50090-2444
11-digit product format
500902444
Labeler code
50090
Product ID
50090-2444_bcf28f1c-6595-4c9d-914c-3f6fc09a8cf9
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
250 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 SODIUM250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii023Z5BR09K
Rxcui309092

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
50090-2444-02023-02-07C16284748780-1f386c64a-075e-0266-e053-dadaa90a7c1aCeftriaxone for Injection, USP Rx Only
50090-2444-02023-01-30C16284748780-1f386c64a-075e-0266-e053-dadaa90a7c1aCeftriaxone for Injection, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2444-0Ceftriaxone Sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1016
50090-2444-0Ceftriaxone Sodium1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2444-0EA - Each50090-244448037adf-6770-4fe7-8cb8-a0781cffbac612019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2444CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [A-S MEDICATION SOLUTIONS]16Current NDC, Legacy NDC, 2 package rows20240201_ff8e830a-c288-46fb-9e19-ec2017943c07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309092cefTRIAXone 250 MG InjectionPSNff8e830a-c288-46fb-9e19-ec2017943c0716
309092ceftriaxone 250 MG InjectionSCDff8e830a-c288-46fb-9e19-ec2017943c0716
309092ceftriaxone 250 MG (as ceftriaxone sodium) InjectionSYff8e830a-c288-46fb-9e19-ec2017943c0716

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2444-05009024440010 VIAL, SINGLE-USE in 1 CARTON (50090-2444-0) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE2016-08-080000-00-00NoNoCurrent