Ceftriaxone

Product NDC
0143-9768
11-digit product format
001439768
Labeler code
0143
Product ID
0143-9768_c4d2239c-f0a2-4ef8-853c-3ce83490d7e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065328
Marketing category
ANDA
Marketing start
2009-08-06
Marketing end
0000-00-00
Substance
CEFTRIAXONE SODIUM
Active strength
10 g/100mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0143-9768-462020-09-27C16284748780-1ab0e2407-33df-f274-e053-dbdaa90a6471Ceftriaxone for Injection
0143-9768-462020-09-25C16284748780-1ab0e2407-33df-f274-e053-dbdaa90a6471Ceftriaxone for Injection
0143-9768-462020-07-22C16284748780-1ab0e2407-33df-f274-e053-dbdaa90a6471Ceftriaxone for Injection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9768-01Ceftriaxone100 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION1008
0143-9768-46Ceftriaxone1 in 1 BOXINJECTION, POWDER, FOR SOLUTION18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFTRIAXONE SODIUMACTIVE INGREDIENT023Z5BR09KCEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP]7
CEFTRIAXONEACTIVE MOIETY75J73V1629CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9768CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]8Legacy NDC, 2 package rows20191231_e38c48f6-4d07-422b-9bb2-3c1025946e86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309090cefTRIAXone 100 MG/ML Injectable SolutionPSNe38c48f6-4d07-422b-9bb2-3c1025946e868
309090ceftriaxone 100 MG/ML Injectable SolutionSCDe38c48f6-4d07-422b-9bb2-3c1025946e868
309090ceftriaxone (as ceftriaxone sodium) 10 GM per 100 ML Injectable SolutionSYe38c48f6-4d07-422b-9bb2-3c1025946e868
309090ceftriaxone (as ceftriaxone sodium) 100 GM per 1000 ML Injectable SolutionSYe38c48f6-4d07-422b-9bb2-3c1025946e868

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
0143-9768-0100143976801100 mL in 1 VIAL100 mlHistorical
0143-9768-46001439768461 in 1 BOXHistorical