Aztreonam
Approved
Approval ID
302fd27d-0a22-44ea-91fb-1b1ffcf17a1f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 30, 2022
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
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 Code63323-402
Application NumberANDA065439
Product Classification
M
Marketing Category
C73584
G
Generic Name
AZTREONAM
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMay 18, 2021
FDA Product Classification
INGREDIENTS (2)
ARGININEInactive
Quantity: 1.56 g in 1 1
Code: 94ZLA3W45F
Classification: IACT
AZTREONAMActive
Quantity: 2 g in 1 1
Code: G2B4VE5GH8
Classification: ACTIB
AZTREONAM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-401
Application NumberANDA065439
Product Classification
M
Marketing Category
C73584
G
Generic Name
AZTREONAM
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateMay 18, 2021
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