FDA.reportPublic FDA data

Ceftriaxone Sodium

Product NDC
85766-128
11-digit product format
857660128
Labeler code
85766
Product ID
85766-128_50323753-188c-7c42-e063-6294a90ac31b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sportpharm LLC
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ceftriaxone Sodium
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85766-128-01Ceftriaxone Sodium1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION12
85766-128-01Ceftriaxone Sodium1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION12
85766-128-10Ceftriaxone Sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION102
85766-128-10Ceftriaxone Sodium1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665005cefTRIAXone 500 MG InjectionPSN9a937e47-8c36-4656-83e1-b3c18ed9bac32
1665005ceftriaxone 500 MG InjectionSCD9a937e47-8c36-4656-83e1-b3c18ed9bac32
1665005ceftriaxone 500 MG (as ceftriaxone sodium) InjectionSY9a937e47-8c36-4656-83e1-b3c18ed9bac32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85766-128-01857660128011 VIAL, SINGLE-USE in 1 CARTON (85766-128-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE2025-12-03NoNoHistorical
85766-128-108576601281010 VIAL, SINGLE-USE in 1 CARTON (85766-128-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE2025-12-03NoNoHistorical