FDA.reportPublic FDA data

Ceftriaxone Sodium

Product NDC
50090-1875
11-digit product format
500901875
Labeler code
50090
Product ID
50090-1875_48bba686-fc8a-4b5c-97c8-45e926912fd7
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
50090-1875-02023-02-07C16284748780-1f386c64a-16e3-0266-e053-dadaa90a7c1aCeftriaxone for Injection, USP
50090-1875-02023-01-30C16284748780-1f386c64a-16e3-0266-e053-dadaa90a7c1aCeftriaxone for Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1875-0Ceftriaxone Sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1013
50090-1875-0Ceftriaxone Sodium1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1875-0EA - Each50090-1875ee9e6f5c-9217-4aab-8d35-97997ca8227312018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1875CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [A-S MEDICATION SOLUTIONS]13Current NDC, Legacy NDC, 2 package rows20240201_1aa0a4ee-1b39-4c3d-a7a3-33dded6fe28c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309092cefTRIAXone 250 MG InjectionPSN1aa0a4ee-1b39-4c3d-a7a3-33dded6fe28c13
309092ceftriaxone 250 MG InjectionSCD1aa0a4ee-1b39-4c3d-a7a3-33dded6fe28c13
309092ceftriaxone 250 MG (as ceftriaxone sodium) InjectionSY1aa0a4ee-1b39-4c3d-a7a3-33dded6fe28c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1875-05009018750010 VIAL, SINGLE-USE in 1 CARTON (50090-1875-0) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE2015-06-160000-00-00NoNoCurrent