FDA.reportPublic FDA data

Ceftriaxone Sodium

Product NDC
76420-596
11-digit product format
764200596
Labeler code
76420
Product ID
76420-596_045b6441-f12b-f2b4-e063-6394a90ad0ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Asclemed USA, Inc.
Application
ANDA203702
Marketing category
ANDA
Marketing start
2017-06-30
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

Additional Listing Data#

Finished product
Yes
Brand name base
Ceftriaxone Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFTRIAXONE SODIUM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii023Z5BR09K
Rxcui1665005

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
76420-596-01Ceftriaxone Sodium1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION11
76420-596-01Ceftriaxone Sodium1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION11
76420-596-10Ceftriaxone Sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION101
76420-596-10Ceftriaxone Sodium1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-596CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [ASCLEMED USA, INC.]1Current NDC, 4 package rows20230906_f01cf0e5-caaf-4759-ba21-50f3aceff523.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665005cefTRIAXone 500 MG InjectionPSNf01cf0e5-caaf-4759-ba21-50f3aceff5231
1665005ceftriaxone 500 MG InjectionSCDf01cf0e5-caaf-4759-ba21-50f3aceff5231
1665005ceftriaxone 500 MG (as ceftriaxone sodium) InjectionSYf01cf0e5-caaf-4759-ba21-50f3aceff5231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76420-596-01764200596011 VIAL, SINGLE-USE in 1 CARTON (76420-596-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE2023-09-02NoNoCurrent
76420-596-107642005961010 VIAL, SINGLE-USE in 1 CARTON (76420-596-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE2023-09-02NoNoCurrent