Ceftriaxone

Product NDC
0143-9678
11-digit product format
001439678
Labeler code
0143
Product ID
0143-9678_e9f12b84-2885-442d-b53c-0fd5a9946d38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA090701
Marketing category
ANDA
Marketing start
2017-10-04
Substance
CEFTRIAXONE SODIUM
Active strength
10 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 SODIUM10 g/1

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
0143-9678-01Ceftriaxone1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9678-01EA - Each0143-96785aac099a-c0cf-4497-9418-2336740e9ed012019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9678CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]2Current NDC, Legacy NDC, 1 package rows20220820_1f8776bd-4f5b-427a-849a-6b8338f7997d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309090cefTRIAXone 100 MG/ML Injectable SolutionPSN1f8776bd-4f5b-427a-849a-6b8338f7997d2
309090ceftriaxone 100 MG/ML Injectable SolutionSCD1f8776bd-4f5b-427a-849a-6b8338f7997d2
309090ceftriaxone (as ceftriaxone sodium) 10 GM per 100 ML Injectable SolutionSY1f8776bd-4f5b-427a-849a-6b8338f7997d2
309090ceftriaxone (as ceftriaxone sodium) 100 GM per 1000 ML Injectable SolutionSY1f8776bd-4f5b-427a-849a-6b8338f7997d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0143-9678-01001439678011 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (0143-9678-01) 2017-10-040000-00-00NoNoCurrent