FDA.reportPublic FDA data

Ceftriaxone

Product NDC
0338-5003
11-digit product format
003385003
Labeler code
0338
Product ID
0338-5003_e6debc12-1f25-437c-970e-607f4953c7f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Company
Application
ANDA065224
Marketing category
ANDA
Marketing start
2005-08-23
Substance
CEFTRIAXONE SODIUM
Active strength
2 g/50mL
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 SODIUM2 g/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii023Z5BR09K
Rxcui1665021, 1665046

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
67ae10d0-6c6a-4d52-a629-da83321859b9Product name320190201
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
01b0d089-049b-4c6d-8dfe-1bffad9be307Product name220180807
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
2d5083fe-71de-4fce-8d67-e9049cba775cProduct name120150107
1037f4ca-3bea-c9c4-2af4-fa6387b0e81eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-5003-41Ceftriaxone24 in 1 CASEINJECTION, SOLUTION2426
0338-5003-41Ceftriaxone50 mL in 1 BAGINJECTION, SOLUTION5026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-5003-41ML - Milliliter0338-5003686b9b86-b353-48a4-9ed2-59c6e27bf7fa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFTRIAXONE SODIUMACTIVE INGREDIENT023Z5BR09KCEFTRIAXONE (CEFTRIAXONE SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]14
CEFTRIAXONEACTIVE MOIETY75J73V1629CEFTRIAXONE (CEFTRIAXONE SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]14
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GCEFTRIAXONE (CEFTRIAXONE SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]14
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCEFTRIAXONE (CEFTRIAXONE SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]14
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICEFTRIAXONE (CEFTRIAXONE SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]14
WATERINACTIVE INGREDIENT059QF0KO0RCEFTRIAXONE (CEFTRIAXONE SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-5003CEFTRIAXONE (CEFTRIAXONE SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY]25Current NDC, Legacy NDC, 2 package rows20250522_4c5c2d3f-5038-41a1-a2fe-4dcd048dbac1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665021cefTRIAXone 1 GM InjectionPSN4c5c2d3f-5038-41a1-a2fe-4dcd048dbac126
1665046cefTRIAXone 2 GM InjectionPSN4c5c2d3f-5038-41a1-a2fe-4dcd048dbac126
1665021ceftriaxone 1000 MG InjectionSCD4c5c2d3f-5038-41a1-a2fe-4dcd048dbac126
1665046ceftriaxone 2000 MG InjectionSCD4c5c2d3f-5038-41a1-a2fe-4dcd048dbac126
1665021ceftriaxone 1 GM (as ceftriaxone sodium) InjectionSY4c5c2d3f-5038-41a1-a2fe-4dcd048dbac126
1665046ceftriaxone 2 GM (as ceftriaxone sodium) InjectionSY4c5c2d3f-5038-41a1-a2fe-4dcd048dbac126

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-5003-410033850034124 BAG in 1 CASE (0338-5003-41) / 50 mL in 1 BAG24 bag2005-08-230000-00-00NoNoCurrent