MedPath

Ceftriaxone

Ceftriaxone for Injection, USP

Approved
Approval ID

befd73ff-cb3b-4543-8a8e-bdb9b7fc1ff0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 19, 2023

Manufacturers
FDA

WG Critical Care, LLC

DUNS: 829274633

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 Code44567-701
Application NumberANDA065329
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ceftriaxone
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateOctober 19, 2023
FDA Product Classification

INGREDIENTS (2)

CEFTRIAXONE SODIUMActive
Quantity: 1 g in 1 1
Code: 023Z5BR09K
Classification: ACTIM
NATURAL LATEX RUBBERInactive
Quantity: 0 1 in 1 1
Code: 2LQ0UUW8IN
Classification: CNTM

Ceftriaxone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code44567-700
Application NumberANDA065329
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ceftriaxone
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateOctober 19, 2023
FDA Product Classification

INGREDIENTS (2)

CEFTRIAXONE SODIUMActive
Quantity: 500 mg in 1 1
Code: 023Z5BR09K
Classification: ACTIM
NATURAL LATEX RUBBERInactive
Quantity: 0 1 in 1 1
Code: 2LQ0UUW8IN
Classification: CNTM

Ceftriaxone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code44567-702
Application NumberANDA065329
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ceftriaxone
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateOctober 19, 2023
FDA Product Classification

INGREDIENTS (2)

CEFTRIAXONE SODIUMActive
Quantity: 2 g in 1 1
Code: 023Z5BR09K
Classification: ACTIM
NATURAL LATEX RUBBERInactive
Quantity: 0 1 in 1 1
Code: 2LQ0UUW8IN
Classification: CNTM

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Ceftriaxone - FDA Drug Approval Details