FDA.reportPublic FDA data

Ceftriaxone Sodium

Product NDC
0781-3207
11-digit product format
007813207
Labeler code
0781
Product ID
0781-3207_371d8db2-5d67-4339-92b7-aee2a52b2293
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA065169
Marketing category
ANDA
Marketing start
2005-05-09
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

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
0781-3207-85Ceftriaxone Sodium1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION124
0781-3207-85Ceftriaxone Sodium1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION124
0781-3207-95Ceftriaxone Sodium1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION124
0781-3207-95Ceftriaxone Sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3207-85EA - Each0781-3207a5bdd249-1c19-47cd-a843-67606f38ece212012-07-24
0781-3207-95EA - Each0781-3207b45a2ddf-2e2e-4c19-9fe2-76682cb0c32612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFTRIAXONE SODIUMACTIVE INGREDIENT023Z5BR09KCEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]17
CEFTRIAXONEACTIVE MOIETY75J73V1629CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3207CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]23Current NDC, Legacy NDC, 4 package rows20250416_de028434-46cf-44f6-8ac6-889c7c6943b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665021cefTRIAXone 1 GM InjectionPSNde028434-46cf-44f6-8ac6-889c7c6943b324
1665046cefTRIAXone 2 GM InjectionPSNde028434-46cf-44f6-8ac6-889c7c6943b324
309092cefTRIAXone 250 MG InjectionPSNde028434-46cf-44f6-8ac6-889c7c6943b324
1665005cefTRIAXone 500 MG InjectionPSNde028434-46cf-44f6-8ac6-889c7c6943b324
1665021ceftriaxone 1000 MG InjectionSCDde028434-46cf-44f6-8ac6-889c7c6943b324
1665046ceftriaxone 2000 MG InjectionSCDde028434-46cf-44f6-8ac6-889c7c6943b324
309092ceftriaxone 250 MG InjectionSCDde028434-46cf-44f6-8ac6-889c7c6943b324
1665005ceftriaxone 500 MG InjectionSCDde028434-46cf-44f6-8ac6-889c7c6943b324
1665021ceftriaxone 1 GM (as ceftriaxone sodium) InjectionSYde028434-46cf-44f6-8ac6-889c7c6943b324
1665046ceftriaxone 2 GM (as ceftriaxone sodium) InjectionSYde028434-46cf-44f6-8ac6-889c7c6943b324
309092ceftriaxone 250 MG (as ceftriaxone sodium) InjectionSYde028434-46cf-44f6-8ac6-889c7c6943b324
1665005ceftriaxone 500 MG (as ceftriaxone sodium) InjectionSYde028434-46cf-44f6-8ac6-889c7c6943b324
1665005cefTRIAXone 500 MG InjectionPSNd0d664f7-1851-484e-ab18-99e2a83eb4743
1665005ceftriaxone 500 MG InjectionSCDd0d664f7-1851-484e-ab18-99e2a83eb4743
1665005ceftriaxone 500 MG (as ceftriaxone sodium) InjectionSYd0d664f7-1851-484e-ab18-99e2a83eb4743

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-3207-85007813207851 VIAL, SINGLE-USE in 1 CARTON (0781-3207-85) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE2005-05-090000-00-00NoNoCurrent
0781-3207-950078132079510 VIAL, SINGLE-USE in 1 CARTON (0781-3207-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE2005-05-090000-00-00NoNoCurrent