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Ceftriaxone Sodium

Ceftriaxone for Injection, USP

Approved
Approval ID

03283208-8616-4117-9d2b-aa8046017a4f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 10, 2024

Manufacturers
FDA

Hospira, Inc

DUNS: 141588017

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ceftriaxone Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0409-7332
Application NumberANDA065169
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ceftriaxone Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateJune 15, 2017
FDA Product Classification

INGREDIENTS (1)

CEFTRIAXONE SODIUMActive
Quantity: 1 g in 1 1
Code: 023Z5BR09K
Classification: ACTIM

Ceftriaxone Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0409-7337
Application NumberANDA065169
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ceftriaxone Sodium
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJune 15, 2017
FDA Product Classification

INGREDIENTS (1)

CEFTRIAXONE SODIUMActive
Quantity: 250 mg in 1 1
Code: 023Z5BR09K
Classification: ACTIM

Ceftriaxone Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0409-7338
Application NumberANDA065169
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ceftriaxone Sodium
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJune 15, 2017
FDA Product Classification

INGREDIENTS (1)

CEFTRIAXONE SODIUMActive
Quantity: 500 mg in 1 1
Code: 023Z5BR09K
Classification: ACTIM

Ceftriaxone Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0409-7335
Application NumberANDA065169
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ceftriaxone Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateJune 15, 2017
FDA Product Classification

INGREDIENTS (1)

CEFTRIAXONE SODIUMActive
Quantity: 2 g in 1 1
Code: 023Z5BR09K
Classification: ACTIM

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Ceftriaxone Sodium - FDA Drug Approval Details