MedPath

Ceftriaxone

CEFTRIAXONE FOR INJECTION, USP

Approved
Approval ID

e6ac87e3-481e-4884-ac06-1fd7279cad62

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 7, 2012

Manufacturers
FDA

Cephazone Pharma LLC

DUNS: 138954909

Products 6

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 Code68330-005
Application NumberANDA065294
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ceftriaxone
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateAugust 31, 2012
FDA Product Classification

INGREDIENTS (1)

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

Ceftriaxone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68330-002
Application NumberANDA065294
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ceftriaxone
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateAugust 31, 2012
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 Code68330-003
Application NumberANDA065294
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ceftriaxone
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateAugust 31, 2012
FDA Product Classification

INGREDIENTS (1)

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

Ceftriaxone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68330-004
Application NumberANDA065294
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ceftriaxone
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateAugust 31, 2012
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 Code68330-001
Application NumberANDA065294
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ceftriaxone
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateAugust 31, 2012
FDA Product Classification

INGREDIENTS (1)

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

Ceftriaxone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68330-006
Application NumberANDA065294
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ceftriaxone
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateAugust 31, 2012
FDA Product Classification

INGREDIENTS (1)

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

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