FDA.reportPublic FDA data

Ceftriaxone Sodium

Product NDC
0781-3210
11-digit product format
007813210
Labeler code
0781
Product ID
0781-3210_fae8140e-99cc-45f1-84d7-676288a2f327
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA065168
Marketing category
ANDA
Marketing start
2005-05-17
Substance
CEFTRIAXONE SODIUM
Active strength
10 g/100mL
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 SODIUM10 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii023Z5BR09K
Rxcui309090

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
0781-3210-46Ceftriaxone Sodium1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION125
0781-3210-46Ceftriaxone Sodium100 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, FOR SOLUTION10025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3210-46EA - Each0781-32101678bce7-f121-4733-8ef7-672a4ae604ab12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFTRIAXONE SODIUMACTIVE INGREDIENT023Z5BR09KCEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]19
CEFTRIAXONEACTIVE MOIETY75J73V1629CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3210CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]24Current NDC, Legacy NDC, 2 package rows20241215_53df951b-2eee-44b1-bae2-df7ed85bc0ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309090cefTRIAXone 100 MG/ML Injectable SolutionPSN53df951b-2eee-44b1-bae2-df7ed85bc0ed25
309090ceftriaxone 100 MG/ML Injectable SolutionSCD53df951b-2eee-44b1-bae2-df7ed85bc0ed25
309090ceftriaxone (as ceftriaxone sodium) 10 GM per 100 ML Injectable SolutionSY53df951b-2eee-44b1-bae2-df7ed85bc0ed25
309090ceftriaxone (as ceftriaxone sodium) 100 GM per 1000 ML Injectable SolutionSY53df951b-2eee-44b1-bae2-df7ed85bc0ed25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-3210-46007813210461 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0781-3210-46) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE2005-05-170000-00-00NoNoCurrent