FDA.reportPublic FDA data

Ceftriaxone Sodium

Product NDC
60505-6148
11-digit product format
605056148
Labeler code
60505
Product ID
60505-6148_0432e6c3-ad77-726c-e063-6294a90a798c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Apotex Corp.
Application
ANDA203702
Marketing category
ANDA
Marketing start
2017-06-30
Substance
CEFTRIAXONE SODIUM
Active strength
1 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 SODIUM1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii023Z5BR09K
Rxcui309092, 1665005, 1665021, 1665046

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
60505-6148-0Ceftriaxone Sodium1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION111
60505-6148-0Ceftriaxone Sodium1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION111
60505-6148-4Ceftriaxone Sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1011
60505-6148-4Ceftriaxone Sodium1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6148-0EA - Each60505-6148880903da-fbe2-40f6-a953-69e15a46a0e112017-07-07
60505-6148-4EA - Each60505-6148ffd9c5a3-1afc-4360-b573-abb91add70d812017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6148CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [APOTEX CORP.]11Current NDC, Legacy NDC, 4 package rows20230831_5116231f-82d1-44be-b08e-560c9a50e5c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665021cefTRIAXone 1 GM InjectionPSN5116231f-82d1-44be-b08e-560c9a50e5c511
1665046cefTRIAXone 2 GM InjectionPSN5116231f-82d1-44be-b08e-560c9a50e5c511
309092cefTRIAXone 250 MG InjectionPSN5116231f-82d1-44be-b08e-560c9a50e5c511
1665005cefTRIAXone 500 MG InjectionPSN5116231f-82d1-44be-b08e-560c9a50e5c511
1665021ceftriaxone 1000 MG InjectionSCD5116231f-82d1-44be-b08e-560c9a50e5c511
1665046ceftriaxone 2000 MG InjectionSCD5116231f-82d1-44be-b08e-560c9a50e5c511
309092ceftriaxone 250 MG InjectionSCD5116231f-82d1-44be-b08e-560c9a50e5c511
1665005ceftriaxone 500 MG InjectionSCD5116231f-82d1-44be-b08e-560c9a50e5c511
1665021ceftriaxone 1 GM (as ceftriaxone sodium) InjectionSY5116231f-82d1-44be-b08e-560c9a50e5c511
1665046ceftriaxone 2 GM (as ceftriaxone sodium) InjectionSY5116231f-82d1-44be-b08e-560c9a50e5c511
309092ceftriaxone 250 MG (as ceftriaxone sodium) InjectionSY5116231f-82d1-44be-b08e-560c9a50e5c511
1665005ceftriaxone 500 MG (as ceftriaxone sodium) InjectionSY5116231f-82d1-44be-b08e-560c9a50e5c511
1665021cefTRIAXone 1 GM InjectionPSNf1f94d8c-c82c-4675-aa2c-ece816a7c2545
1665021ceftriaxone 1000 MG InjectionSCDf1f94d8c-c82c-4675-aa2c-ece816a7c2545
1665021ceftriaxone 1 GM (as ceftriaxone sodium) InjectionSYf1f94d8c-c82c-4675-aa2c-ece816a7c2545
1665021cefTRIAXone 1 GM InjectionPSN85ce4f8b-77e0-48bf-9f57-93f1478befa22
1665021cefTRIAXone 1 GM InjectionPSN42ba7a9d-7d2b-4eac-af59-897151a8c9242
1665021ceftriaxone 1000 MG InjectionSCD42ba7a9d-7d2b-4eac-af59-897151a8c9242
1665021ceftriaxone 1000 MG InjectionSCD85ce4f8b-77e0-48bf-9f57-93f1478befa22
1665021ceftriaxone 1 GM (as ceftriaxone sodium) InjectionSY85ce4f8b-77e0-48bf-9f57-93f1478befa22
1665021ceftriaxone 1 GM (as ceftriaxone sodium) InjectionSY42ba7a9d-7d2b-4eac-af59-897151a8c9242

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-6148-0605056148001 VIAL, SINGLE-USE in 1 CARTON (60505-6148-0) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE2020-03-030000-00-00NoNoCurrent
60505-6148-46050561480410 VIAL, SINGLE-USE in 1 CARTON (60505-6148-4) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE2017-06-300000-00-00NoNoCurrent