AZACTAM
AZACTAM (aztreonam for injection, USP)
Approved
Approval ID
9a105eaf-ee77-4016-beeb-d425a5565db2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 17, 2023
Manufacturers
FDA
E.R. Squibb & Sons, L.L.C.
DUNS: 011550092
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 Code0003-2560
Application NumberNDA050580
Product Classification
M
Marketing Category
C73594
G
Generic Name
AZTREONAM
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateSeptember 27, 2022
FDA Product Classification
INGREDIENTS (2)
aztreonamActive
Quantity: 1 g in 1 1
Code: G2B4VE5GH8
Classification: ACTIB
arginineInactive
Quantity: 0.78 g in 1 1
Code: 94ZLA3W45F
Classification: IACT
AZTREONAM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0003-2570
Application NumberNDA050580
Product Classification
M
Marketing Category
C73594
G
Generic Name
AZTREONAM
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateSeptember 27, 2022
FDA Product Classification
INGREDIENTS (2)
arginineInactive
Quantity: 1.54 g in 1 1
Code: 94ZLA3W45F
Classification: IACT
aztreonamActive
Quantity: 2 g in 1 1
Code: G2B4VE5GH8
Classification: ACTIB
Drug Labeling Information
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 3/17/2023
HOW SUPPLIED
AZACTAM**®**** (aztreonam for injection, USP)**
Single-dose vials:
|
•** 1 gram/vial:** |
Packages of 10 |
NDC 0003-2560-16 |
|
•** 2 grams/vial:** |
Packages of 10 |
NDC 0003-2570-16 |
Storage
Store in original package at 20°C to 25°C (68°F to 77°F) [see USP controlled room temperature]; avoid excessive heat.