FDA.reportPublic FDA data

Ceftriaxone Sodium

Product NDC
50090-3838
11-digit product format
500903838
Labeler code
50090
Product ID
50090-3838_f3d65432-050d-4e4f-8cb7-2d20d230a350
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
A-S Medication Solutions
Application
ANDA203702
Marketing category
ANDA
Marketing start
2017-06-30
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
50090-3838-02023-02-07C16284748780-1f386c649-ace0-0266-e053-dadaa90a7c1aCeftriaxone for Injection, USP
50090-3838-02023-01-30C16284748780-1f386c649-ace0-0266-e053-dadaa90a7c1aCeftriaxone for Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3838-0Ceftriaxone Sodium1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION19
50090-3838-0Ceftriaxone Sodium1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3838-0EA - Each50090-38388542b68c-c841-46a9-97f3-98b8d6a4b93e12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3838CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20240821_53415af6-4072-4339-83e2-d870ae02a0e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665005cefTRIAXone 500 MG InjectionPSN53415af6-4072-4339-83e2-d870ae02a0e29
1665005ceftriaxone 500 MG InjectionSCD53415af6-4072-4339-83e2-d870ae02a0e29
1665005ceftriaxone 500 MG (as ceftriaxone sodium) InjectionSY53415af6-4072-4339-83e2-d870ae02a0e29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3838-0500903838001 VIAL, SINGLE-USE in 1 CARTON (50090-3838-0) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE2018-11-150000-00-00NoNoCurrent