Ceftriaxone
Ceftriaxone for Injection, USP
Approved
Approval ID
7ea1db43-40fa-417b-8911-ae98092070a0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2023
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ceftriaxone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-347
Application NumberANDA065329
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ceftriaxone
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateSeptember 30, 2023
FDA Product Classification
INGREDIENTS (1)
CEFTRIAXONE SODIUMActive
Quantity: 2 g in 1 1
Code: 023Z5BR09K
Classification: ACTIM
Ceftriaxone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-345
Application NumberANDA065329
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ceftriaxone
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateSeptember 30, 2023
FDA Product Classification
INGREDIENTS (1)
CEFTRIAXONE SODIUMActive
Quantity: 500 mg in 1 1
Code: 023Z5BR09K
Classification: ACTIM
Ceftriaxone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-346
Application NumberANDA065329
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ceftriaxone
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateSeptember 30, 2023
FDA Product Classification
INGREDIENTS (1)
CEFTRIAXONE SODIUMActive
Quantity: 1 g in 1 1
Code: 023Z5BR09K
Classification: ACTIM