Ceftriaxone

Product NDC
0143-9858
11-digit product format
001439858
Labeler code
0143
Product ID
0143-9858_22f5b167-43fa-4fdf-9687-506a02e372e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065342
Marketing category
ANDA
Marketing start
2008-01-10
Substance
CEFTRIAXONE SODIUM
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ceftriaxone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFTRIAXONE SODIUM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii023Z5BR09K
Rxcui309092, 1665005, 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
0143-9858-01Ceftriaxone1 in 1 VIALINJECTION, POWDER, FOR SOLUTION117
0143-9858-25Ceftriaxone25 in 1 BOXINJECTION, POWDER, FOR SOLUTION2517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9858-01EA - Each0143-98587599af8c-9bff-4ab9-ba3b-02c3e294f5af12015-05-05
0143-9858-25EA - Each0143-9858b2e80b0b-c33f-4167-a9f8-92e02eb97f6c12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9858CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]16Current NDC, Legacy NDC, 2 package rows20230312_8351aa37-552d-471d-b293-c564dcb6ec29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665021cefTRIAXone 1 GM InjectionPSN8351aa37-552d-471d-b293-c564dcb6ec2917
1665046cefTRIAXone 2 GM InjectionPSN8351aa37-552d-471d-b293-c564dcb6ec2917
309092cefTRIAXone 250 MG InjectionPSN8351aa37-552d-471d-b293-c564dcb6ec2917
1665005cefTRIAXone 500 MG InjectionPSN8351aa37-552d-471d-b293-c564dcb6ec2917
1665021ceftriaxone 1000 MG InjectionSCD8351aa37-552d-471d-b293-c564dcb6ec2917
1665046ceftriaxone 2000 MG InjectionSCD8351aa37-552d-471d-b293-c564dcb6ec2917
309092ceftriaxone 250 MG InjectionSCD8351aa37-552d-471d-b293-c564dcb6ec2917
1665005ceftriaxone 500 MG InjectionSCD8351aa37-552d-471d-b293-c564dcb6ec2917
1665021ceftriaxone 1 GM (as ceftriaxone sodium) InjectionSY8351aa37-552d-471d-b293-c564dcb6ec2917
1665046ceftriaxone 2 GM (as ceftriaxone sodium) InjectionSY8351aa37-552d-471d-b293-c564dcb6ec2917
309092ceftriaxone 250 MG (as ceftriaxone sodium) InjectionSY8351aa37-552d-471d-b293-c564dcb6ec2917
1665005ceftriaxone 500 MG (as ceftriaxone sodium) InjectionSY8351aa37-552d-471d-b293-c564dcb6ec2917
1665005cefTRIAXone 500 MG InjectionPSNf449e25d-2e52-4a92-9dd5-1e58b3009a9e10
1665005ceftriaxone 500 MG InjectionSCDf449e25d-2e52-4a92-9dd5-1e58b3009a9e10
1665005ceftriaxone 500 MG (as ceftriaxone sodium) InjectionSYf449e25d-2e52-4a92-9dd5-1e58b3009a9e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9858-01001439858011 in 1 VIALHistorical
0143-9858-250014398582525 VIAL in 1 BOX (0143-9858-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9858-01) 25 vial2008-01-100000-00-00NoNoCurrent