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Aztreonam

Aztreonam for Injection, USP

Approved
Approval ID

d4500795-3b07-4a7d-b432-73cafbb3dbc6

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 9, 2024

Manufacturers
FDA

Hospira, Inc.

DUNS: 141588017

Products 2

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

Aztreonam

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0409-0829
Application NumberANDA206517
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aztreonam
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateJanuary 9, 2024
FDA Product Classification

INGREDIENTS (2)

ARGININEInactive
Quantity: 780 mg in 1 1
Code: 94ZLA3W45F
Classification: IACT
AZTREONAMActive
Quantity: 1 g in 1 1
Code: G2B4VE5GH8
Classification: ACTIB

Aztreonam

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0409-0830
Application NumberANDA206517
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aztreonam
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateJanuary 9, 2024
FDA Product Classification

INGREDIENTS (2)

AZTREONAMActive
Quantity: 2 g in 1 1
Code: G2B4VE5GH8
Classification: ACTIB
ARGININEInactive
Quantity: 1.56 g in 1 1
Code: 94ZLA3W45F
Classification: IACT

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Aztreonam - FDA Drug Approval Details