FDA.reportPublic FDA data

ceftriaxone

Product NDC
25021-107
11-digit product format
250210107
Labeler code
25021
Product ID
25021-107_71bf5ebd-afe1-4906-86ef-76d7e205ec68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ceftriaxone
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA065329
Marketing category
ANDA
Marketing start
2009-11-05
Substance
CEFTRIAXONE SODIUM
Active strength
2 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFTRIAXONE SODIUM2 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii023Z5BR09K
Rxcui1665005, 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
25021-107-20ceftriaxone25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION2519
25021-107-20ceftriaxone1 in 1 VIALINJECTION, POWDER, FOR SOLUTION119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-107-20EA - Each25021-1071b9c864a-25d9-4c60-b60a-0158036e08b212012-07-24
25021-107-68EA - Each25021-107efd0292f-a384-44ea-ba9a-07b330dcdec212015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ceftriaxone sodiumACTIVE INGREDIENT023Z5BR09KCEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]5
ceftriaxoneACTIVE MOIETY75J73V1629CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-107CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]19Current NDC, Legacy NDC, 2 package rows20231115_5cf93bc5-9e4c-4734-bc02-c7d0ac071022.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665021cefTRIAXone 1 GM InjectionPSN5cf93bc5-9e4c-4734-bc02-c7d0ac07102219
1665046cefTRIAXone 2 GM InjectionPSN5cf93bc5-9e4c-4734-bc02-c7d0ac07102219
1665005cefTRIAXone 500 MG InjectionPSN5cf93bc5-9e4c-4734-bc02-c7d0ac07102219
1665021ceftriaxone 1000 MG InjectionSCD5cf93bc5-9e4c-4734-bc02-c7d0ac07102219
1665046ceftriaxone 2000 MG InjectionSCD5cf93bc5-9e4c-4734-bc02-c7d0ac07102219
1665005ceftriaxone 500 MG InjectionSCD5cf93bc5-9e4c-4734-bc02-c7d0ac07102219
1665021ceftriaxone 1 GM (as ceftriaxone sodium) InjectionSY5cf93bc5-9e4c-4734-bc02-c7d0ac07102219
1665046ceftriaxone 2 GM (as ceftriaxone sodium) InjectionSY5cf93bc5-9e4c-4734-bc02-c7d0ac07102219
1665005ceftriaxone 500 MG (as ceftriaxone sodium) InjectionSY5cf93bc5-9e4c-4734-bc02-c7d0ac07102219

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-107-202502101072025 VIAL in 1 CARTON (25021-107-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL25 vial2009-11-050000-00-00NoNoCurrent
25021-107-682502101076825 VIAL in 1 CARTON (25021-107-68) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL25 vial2015-07-010000-00-00NoNoCurrent